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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01480180
Registration number
NCT01480180
Ethics application status
Date submitted
23/11/2011
Date registered
28/11/2011
Date last updated
23/11/2020
Titles & IDs
Public title
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
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Scientific title
A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A
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Secondary ID [1]
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U1111-1119-7416
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Secondary ID [2]
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NN7088-3859
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Universal Trial Number (UTN)
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Trial acronym
pathfinder™2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Congenital Bleeding Disorder
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Haemophilia A
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - turoctocog alfa pegol
Experimental: Prophylaxis -
Experimental: On-demand -
Treatment: Drugs: turoctocog alfa pegol
Administered i.v.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Incidence Rate of FVIII-inhibitors =0.6 BU: After Approximately 19 Months
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Assessment method [1]
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All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as =0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.
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Timepoint [1]
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After approximately 19 months
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Primary outcome [2]
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Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months
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Assessment method [2]
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Annualised bleeding rate (ABR) is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP.
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Timepoint [2]
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After approximately 19 months
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Primary outcome [3]
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The Incidence Rate of FVIII-inhibitors =0.6 BU: After Approximately 25 Months
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Assessment method [3]
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All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as =0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.
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Timepoint [3]
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After approximately 25 months
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Primary outcome [4]
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Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months
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Assessment method [4]
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ABR is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP.
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Timepoint [4]
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After approximately 25 months
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Primary outcome [5]
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Incidence Rate of FVIII-inhibitors =0.6 BU: At Approximately 80 Months
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Assessment method [5]
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All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as =0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.
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Timepoint [5]
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At approximately 80 months
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Primary outcome [6]
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Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months
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Assessment method [6]
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Annualised bleeding rate (ABR) is the number of bleeding episodes per year reported during the prophylactic treatment with N8-GP.
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Timepoint [6]
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After approximately 80 months
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Secondary outcome [1]
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Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months
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Assessment method [1]
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Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.
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Timepoint [1]
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After approximately 19 months
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Secondary outcome [2]
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Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months
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Assessment method [2]
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Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.
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Timepoint [2]
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After approximately 25 months
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Secondary outcome [3]
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Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months
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Assessment method [3]
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Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.
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Timepoint [3]
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After approximately 80 months
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Secondary outcome [4]
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Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months
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Assessment method [4]
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The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.
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Timepoint [4]
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After approximately 19 months
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Secondary outcome [5]
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Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 25 Months
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Assessment method [5]
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The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.
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Timepoint [5]
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After approximately 25 months
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Secondary outcome [6]
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Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 80 Months
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Assessment method [6]
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The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.
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Timepoint [6]
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After approximately 80 months
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Secondary outcome [7]
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Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 19 Months
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Assessment method [7]
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The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.
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Timepoint [7]
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After approximately 19 months
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Secondary outcome [8]
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Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 25 Months
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Assessment method [8]
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The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.
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Timepoint [8]
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After approximately 25 months
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Secondary outcome [9]
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Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 80 Months
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Assessment method [9]
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The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.
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Timepoint [9]
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After approximately 80 months
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Secondary outcome [10]
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Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 19 Months
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Assessment method [10]
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Number of infusions are presented as average dose used during propphylaxis and on-demand treatment.
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Timepoint [10]
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After approximately 19 months
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Secondary outcome [11]
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Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 25 Months
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Assessment method [11]
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Number of infusions are presented as average dose used during prophylaxis and on-demand treatment.
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Timepoint [11]
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After approximately 25 months
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Secondary outcome [12]
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Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 80 Months
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Assessment method [12]
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Number of infusions are presented as average dose used during prophylaxis and on-demand treatment.
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Timepoint [12]
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After approximately 80 months
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Secondary outcome [13]
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Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 19 Months
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Assessment method [13]
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The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.
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Timepoint [13]
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After approximately 19 months
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Secondary outcome [14]
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Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 25 Months
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Assessment method [14]
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The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.
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Timepoint [14]
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After approximately 25 months
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Secondary outcome [15]
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Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 80 Months
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Assessment method [15]
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The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.
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Timepoint [15]
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After approximately 80 months
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Secondary outcome [16]
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Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 19 Months
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Assessment method [16]
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The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.
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Timepoint [16]
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After approximately 19 months
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Secondary outcome [17]
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Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 25 Months
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Assessment method [17]
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The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.
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Timepoint [17]
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After approximately 25 months
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Secondary outcome [18]
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Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 80 Months
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Assessment method [18]
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The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.
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Timepoint [18]
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After approximately 80 months
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Secondary outcome [19]
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Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months
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Assessment method [19]
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Recovery and trough levels of FVIII:C was reported for all participants at Visit 3 (Week 4) and end of main phase (approx. 19 months). The data was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N8-GP product specific standard (PSS) as a calibrator.
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Timepoint [19]
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After approximately 19 months
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Secondary outcome [20]
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Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 25 Months
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Assessment method [20]
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Recovery and trough levels of FVIII:C was reported for all participants at the end of extension phase 1 study (approx. 25 months). The data was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N8-GP product specific standard (PSS) as a calibrator.
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Timepoint [20]
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After approximately 25 months
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Secondary outcome [21]
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Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 80 Months
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Assessment method [21]
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Since patients were allowed to change prophylaxis regimen at any time during the extension phase part 2, and since the visit intervals were different for the 2 prophylaxis treatment regimens (Q4D and Q7D), FVIII activity data are reported only as incremental recovery at this timepoint.
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Timepoint [21]
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After approximately 80 months
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Secondary outcome [22]
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Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old) After Approx 19 and 25 Months
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Assessment method [22]
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Reported results are change from baseline (Month 0) measured at end of main phase (approx Month 19) and change from Month 19 at end of Extension 1 (approx Month 25) of the study. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.
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Timepoint [22]
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After approx 19 and 25 months
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Secondary outcome [23]
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Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months
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Assessment method [23]
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Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point.
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Timepoint [23]
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2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
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Secondary outcome [24]
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Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 19 and 25 Months
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Assessment method [24]
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Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The questionnaire was completed by parents of the patients in the 13-16 years old age bracket. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.
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Timepoint [24]
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After approx 19 and 25 months
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Secondary outcome [25]
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Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months
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Assessment method [25]
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Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. The questionnaire was completed by parents of the patients in the 13-16 years old age bracket. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point.
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Timepoint [25]
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2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
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Secondary outcome [26]
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Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approx 19 and 25 Months
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Assessment method [26]
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Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The HAEM-A-QOL (for adults (>=17 years)) assessment included questions on questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.
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Timepoint [26]
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After approx 19 and 25 months
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Secondary outcome [27]
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Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months
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Assessment method [27]
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Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The HAEM-A-QOL (for adults (>=17 years)) assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.
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Timepoint [27]
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2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
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Secondary outcome [28]
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Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months
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Assessment method [28]
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Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The HEMO-SAT (Hematology-satisfaction) assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by patients). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.
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Timepoint [28]
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After approx 19 and 25 months
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Secondary outcome [29]
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Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months
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Assessment method [29]
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Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by patients). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.
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Timepoint [29]
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1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
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Secondary outcome [30]
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Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months
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Assessment method [30]
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The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0). The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by parents). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.
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Timepoint [30]
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After approx 19 and 25 months
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Secondary outcome [31]
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Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months
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Assessment method [31]
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Reported results are from Visit 1 (Month 0), and change from visit 1 upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Max. no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = max. number of participants contributed to the analysis for each time point. The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction. Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.
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Timepoint [31]
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0
2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
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Secondary outcome [32]
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Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approx 19 and 25 Months
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Assessment method [32]
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Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The European quality of life visual analogue scale (EQ5D-VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. A positive change indicates an improvement.
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Timepoint [32]
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After approx 19 and 25 months
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Secondary outcome [33]
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Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months
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Assessment method [33]
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Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The EQ5D-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. A positive change indicates an improvement.
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Timepoint [33]
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1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
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Secondary outcome [34]
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Patient Reported Outcomes - Change in European Quality of Life Utility Index: After Approx 19 and 25 Months
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Assessment method [34]
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Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The European quality of life utility index comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels where 1 indicates better health state (no problems) and 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; a positive change indicates an improvement.
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Timepoint [34]
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After approx 19 and 25 months
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Secondary outcome [35]
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Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months
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Assessment method [35]
0
0
Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It is possible that a patient answers more than one questionnaire in a single time interval. Overall units analysed = Max no. of questionnaires answered by participants for this endpoint. Overall no. of participants analysed = max no. of participants analysed at each time point. This utility index has 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 3 levels where 1 indicates better health state (no problems) and 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; a positive change indicates an improvement.
Query!
Timepoint [35]
0
0
1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Query!
Secondary outcome [36]
0
0
Number of Hospital Admissions During the Trial
Query!
Assessment method [36]
0
0
The number of hospital admissions that took place in the study were reported.
Query!
Timepoint [36]
0
0
After approx 19, 25 and 80 months
Query!
Secondary outcome [37]
0
0
Number of Days at the Hospital During the Trial
Query!
Assessment method [37]
0
0
The mean number of days that participants spent at the hospital during the study were reported.
Query!
Timepoint [37]
0
0
After approx 19, 25 and 80 months
Query!
Secondary outcome [38]
0
0
Number of Admissions to the Emergency Room (ER) During the Trial
Query!
Assessment method [38]
0
0
The number of admissions to the ER that took place in the study were reported for each group.
Query!
Timepoint [38]
0
0
After approx 19, 25 and 80 months
Query!
Secondary outcome [39]
0
0
Number of Days Missing School or Work
Query!
Assessment method [39]
0
0
The mean number of days that participants missed to go to school or work were reported.
Query!
Timepoint [39]
0
0
Approx 19, 25 and 80 months
Query!
Secondary outcome [40]
0
0
Number of Days Using Mobility Aid
Query!
Assessment method [40]
0
0
The mean number of days that participants used any aids for mobility during the study were reported.
Query!
Timepoint [40]
0
0
Approx 19, 25 and 80 months
Query!
Secondary outcome [41]
0
0
Number of Participants Using Pain Medication
Query!
Assessment method [41]
0
0
The number of participants using pain medication during the main plus extension phase 1 of the study (approximately 25 months) and during extension phase 2(approximately 80 months) were reported.
Query!
Timepoint [41]
0
0
After approx 25 and 80 months
Query!
Secondary outcome [42]
0
0
Number of Bleeds Using Pain Medication
Query!
Assessment method [42]
0
0
The mean number of bleeds using pain medication in the main phase of the study (approximately 19 months) were reported.
Query!
Timepoint [42]
0
0
After approx 19 months
Query!
Secondary outcome [43]
0
0
Number of Adverse Events Reported During the Trial Period: After Approximately 19 Months
Query!
Assessment method [43]
0
0
All presented adverse events (AEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.
Query!
Timepoint [43]
0
0
After approx 19 months
Query!
Secondary outcome [44]
0
0
Number of Adverse Events Reported During the Trial Period: After Approximately 25 Months
Query!
Assessment method [44]
0
0
All presented adverse events (AEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.
Query!
Timepoint [44]
0
0
After approx. 25 months
Query!
Secondary outcome [45]
0
0
Number of Adverse Events Reported During the Trial Period: After Approximately 80 Months
Query!
Assessment method [45]
0
0
The number of adverse events observed during the study after approximately 80 months was reported.
Query!
Timepoint [45]
0
0
After approximately 80 months
Query!
Secondary outcome [46]
0
0
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 19 Months
Query!
Assessment method [46]
0
0
All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.
Query!
Timepoint [46]
0
0
After approximately 19 months
Query!
Secondary outcome [47]
0
0
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 25 Months
Query!
Assessment method [47]
0
0
All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.
Query!
Timepoint [47]
0
0
After approximately 25 months
Query!
Secondary outcome [48]
0
0
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 80 Months
Query!
Assessment method [48]
0
0
All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.
Query!
Timepoint [48]
0
0
After approximately 80 months
Query!
Secondary outcome [49]
0
0
Change in Blood Pressure: After Approximately 19 Months
Query!
Assessment method [49]
0
0
The mean change in the systolic and diastolic blood pressure values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).
Query!
Timepoint [49]
0
0
After approximately 19 months
Query!
Secondary outcome [50]
0
0
Change in Blood Pressure: After Approximately 25 Months
Query!
Assessment method [50]
0
0
The mean change in the systolic and diastolic blood pressure values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).
Query!
Timepoint [50]
0
0
After approximately 19 and 25 months
Query!
Secondary outcome [51]
0
0
Change in Blood Pressure: After Approximately 80 Months
Query!
Assessment method [51]
0
0
Change in the blood pressure was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.
Query!
Timepoint [51]
0
0
After approximately 80 months
Query!
Secondary outcome [52]
0
0
Change in Pulse: After Approximately 19 Months
Query!
Assessment method [52]
0
0
The mean change in the pulse values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).
Query!
Timepoint [52]
0
0
After approximately 19 months
Query!
Secondary outcome [53]
0
0
Change in Pulse: After Approximately 25 Months
Query!
Assessment method [53]
0
0
The mean change in the pulse values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).
Query!
Timepoint [53]
0
0
After approximately 25 months
Query!
Secondary outcome [54]
0
0
Change in Pulse: After Approximately 80 Months
Query!
Assessment method [54]
0
0
Change in pulse was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.
Query!
Timepoint [54]
0
0
After approximately 80 months
Query!
Secondary outcome [55]
0
0
Change in Body Temperature: After Approximately 19 Months
Query!
Assessment method [55]
0
0
The mean change in the body temperature values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).
Query!
Timepoint [55]
0
0
After approximately 19 months
Query!
Secondary outcome [56]
0
0
Change in Body Temperature: After Approximately 25 Months
Query!
Assessment method [56]
0
0
The mean change in the body temperature (C) values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).
Query!
Timepoint [56]
0
0
After approximately 25 months
Query!
Secondary outcome [57]
0
0
Change in Body Temperature: After Approximately 80 Months
Query!
Assessment method [57]
0
0
Change in body temperature was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.
Query!
Timepoint [57]
0
0
After approximately 80 months
Query!
Secondary outcome [58]
0
0
Change in Respiratory Rate: After Approximately 19 Months
Query!
Assessment method [58]
0
0
The mean change in the respiratory rate values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).
Query!
Timepoint [58]
0
0
After approximately 19 months
Query!
Secondary outcome [59]
0
0
Change in Respiratory Rate: After Approximately 25 Months
Query!
Assessment method [59]
0
0
The mean change in the respiratory rate (breaths/min) values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).
Query!
Timepoint [59]
0
0
After approximately 25 months
Query!
Secondary outcome [60]
0
0
Change in Respiratory Rate: After Approximately 80 Months
Query!
Assessment method [60]
0
0
Change in respiratory rate was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.
Query!
Timepoint [60]
0
0
After approximately 80 months
Query!
Secondary outcome [61]
0
0
FVIII Activity 30 Min Post -Injection (C30min)
Query!
Assessment method [61]
0
0
FVIII plasma activity was measured after 30 mins of injection. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator
Query!
Timepoint [61]
0
0
Week 0, week 28
Query!
Secondary outcome [62]
0
0
Incremental Recovery (Single Dose and Steady State)
Query!
Assessment method [62]
0
0
Incremental recovery was defined as the dose-normalised activity recorded 30 min after end of injection. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [62]
0
0
Week 0, week 28
Query!
Secondary outcome [63]
0
0
Trough Level (Single Dose and Steady State)
Query!
Assessment method [63]
0
0
Trough level was defined as the plasma FVIII activity recorded immediately before next dose is given. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [63]
0
0
Week 0, week 28
Query!
Secondary outcome [64]
0
0
Area Under the Curve (AUC0-inf)
Query!
Assessment method [64]
0
0
Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf) was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. It is the measure of total plasma exposure. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [64]
0
0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Query!
Secondary outcome [65]
0
0
Area Under the Curve (AUC0-t)
Query!
Assessment method [65]
0
0
Area under the plasma activity versus time profile from time zero to the last measurable activity (AUC0-t) was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [65]
0
0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Query!
Secondary outcome [66]
0
0
Terminal Half Life (t1/2)
Query!
Assessment method [66]
0
0
t½ = ln(2) / ?z, where ?z is the terminal elimination rate constant. The terminal elimination rate constant was estimated using linear regression on the terminal part of the log(activity) versus time profile. This was measured at Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [66]
0
0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Query!
Secondary outcome [67]
0
0
Clearance (CL)
Query!
Assessment method [67]
0
0
Total plasma clearance (CL) of drug after intravenous administration was reported. Clearance was calculated using the formula CL= Dose / AUC(0-inf). This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [67]
0
0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Query!
Secondary outcome [68]
0
0
Mean Residence Time (MRT)
Query!
Assessment method [68]
0
0
MRT = AUMC/AUC(0-inf), where AUMC is the area under the first moment curve, i.e. the area under the curve t·C(t), calculated with the same method as AUC(0-inf) (linear trapezoidal method + extrapolated area). This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [68]
0
0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Query!
Secondary outcome [69]
0
0
Volume of Distribution at Steady State (Vss)
Query!
Assessment method [69]
0
0
Apparent volume of distribution at steady state is a product of the mean residence time and clearance and was calculated using the formula - Vss = CL x MRT. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.
Query!
Timepoint [69]
0
0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Query!
Eligibility
Key inclusion criteria
- Male patients with severe congenital haemophilia A (FVIII activity
below 1%, according to medical records) - Documented history of at least 150 EDs (exposure
days) to other FVIII products - At least 12 years and body weight at least 35 kg (except
for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be
18 years)
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Previous participation in this trial defined as withdrawal
after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or
equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by
medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral
load of more than 400000 copies/mL. If the data is not available in medical records within
last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired
coagulation disorders other than haemophilia A - Previous significant thromboembolic events
(e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined
by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value
at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of
normal reference ranges at central laboratory - Creatinine level equal to or greater than
1.5 times above upper normal limit (according to central laboratory reference ranges) -
Ongoing immune modulating or chemotherapeutic medication
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/01/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/12/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
186
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - South Brisbane
Query!
Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Iowa
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oregon
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Sao Paulo
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Sofia
Query!
Country [25]
0
0
Croatia
Query!
State/province [25]
0
0
Split
Query!
Country [26]
0
0
Croatia
Query!
State/province [26]
0
0
Zagreb
Query!
Country [27]
0
0
Denmark
Query!
State/province [27]
0
0
København Ø
Query!
Country [28]
0
0
Denmark
Query!
State/province [28]
0
0
Århus N
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Bron Cedex
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Kremlin-Bicêtre
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Nantes Cedex 1
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Paris
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Berlin
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Bonn
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Frankfurt/M.
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Hannover
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Homburg
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
München
Query!
Country [39]
0
0
Hungary
Query!
State/province [39]
0
0
Budapest
Query!
Country [40]
0
0
Hungary
Query!
State/province [40]
0
0
Debrecen
Query!
Country [41]
0
0
Israel
Query!
State/province [41]
0
0
Tel-Hashomer
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Firenze
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Milano
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Udine
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Vicenza
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Aichi
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Hiroshima
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Kitakyusyu, Fukuoka
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Nara
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Saitama
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Shimotsuke-shi, Tochigi
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Shizuoka
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Tokyo
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Yokohama-shi, Kanagawa
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Daejeon
Query!
Country [56]
0
0
Malaysia
Query!
State/province [56]
0
0
Kuala Lumpur
Query!
Country [57]
0
0
Malaysia
Query!
State/province [57]
0
0
Selangor Darul Ehsan
Query!
Country [58]
0
0
Netherlands
Query!
State/province [58]
0
0
Groningen
Query!
Country [59]
0
0
Netherlands
Query!
State/province [59]
0
0
Rotterdam
Query!
Country [60]
0
0
Norway
Query!
State/province [60]
0
0
Oslo
Query!
Country [61]
0
0
Puerto Rico
Query!
State/province [61]
0
0
San Juan
Query!
Country [62]
0
0
Russian Federation
Query!
State/province [62]
0
0
Saint-Petersburg
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Country [63]
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Spain
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State/province [63]
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Madrid
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Country [64]
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Spain
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State/province [64]
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0
Málaga
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Country [65]
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Sweden
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State/province [65]
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0
Malmö
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Country [66]
0
0
Switzerland
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State/province [66]
0
0
Genève 14
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Country [67]
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Switzerland
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State/province [67]
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Lausanne
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Country [68]
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Switzerland
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State/province [68]
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Zürich
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Country [69]
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0
Taiwan
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State/province [69]
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Changhua
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Country [70]
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Taiwan
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State/province [70]
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Taipei
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Country [71]
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Turkey
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State/province [71]
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Adana
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Country [72]
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Turkey
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State/province [72]
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Bornova-IZMIR
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Country [73]
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Turkey
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State/province [73]
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Samsun
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Country [74]
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United Kingdom
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State/province [74]
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Basingstoke
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Country [75]
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United Kingdom
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State/province [75]
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Cardiff
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Country [76]
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United Kingdom
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State/province [76]
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London
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Country [77]
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United Kingdom
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State/province [77]
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Oxford
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Country [78]
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United Kingdom
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State/province [78]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is conducted globally. The aim of the trial is to evaluate the safety and
efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC
0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01480180
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Country
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0
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Phone
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Fax
0
0
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Email
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Contact person for public queries
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01480180
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