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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/NCT01736475
Registration number
NCT01736475
Ethics application status
Date submitted
21/11/2012
Date registered
29/11/2012
Date last updated
20/05/2021
Titles & IDs
Public title
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
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Scientific title
A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
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Secondary ID [1]
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2012-003599-38
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Secondary ID [2]
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261201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemophilia A
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Condition category
Condition code
Blood
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Clotting disorders
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Human Genetics and Inherited Disorders
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0
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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
Other interventions - Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
Other interventions - PEGylated Recombinant Factor VIII
Other interventions - PEGylated Recombinant Factor VIII
Other interventions - PEGylated Recombinant Factor VIII
Experimental: Prophylaxis -
Experimental: On-demand -
Other interventions: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
Pharmacokinetic (PK) evaluation of ADVATE
Other interventions: PEGylated Recombinant Factor VIII
Pharmacokinetic (PK) evaluation of BAX 855
Other interventions: PEGylated Recombinant Factor VIII
Prophylaxis treatment
Other interventions: PEGylated Recombinant Factor VIII
On-demand treatment
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Intervention code [1]
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Other interventions
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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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Annualized Bleeding Rate (ABR)
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Assessment method [1]
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Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.
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Timepoint [1]
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9 months
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Secondary outcome [1]
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Rate of Success of BAX 855 for Treatment of Bleeding Episodes
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Assessment method [1]
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Success in the control of bleeding was defined as a rating of excellent or good using the Efficacy Rating Scale for Treatment of Bleeding Episodes measured 24 hours after initiation of treatment for the bleeding episode. EXCELLENT: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. GOOD: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. FAIR: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. NONE: No improvement or condition worsens.
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Timepoint [1]
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At least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm.
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Secondary outcome [2]
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Average Number of BAX 855 Infusions Needed for the Treatment of Bleeding Episodes
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Assessment method [2]
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Timepoint [2]
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From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].
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Secondary outcome [3]
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Number of Participants With =1, 2, 3, 4, 5, 6, or >6 Month Time Intervals Between Bleeding Episodes or no Bleeding Episodes
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Assessment method [3]
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Interval between Bleeds in months was calculated as: Observation period for efficacy (in days)/(number of bleeds)*(12/365.2425)
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Timepoint [3]
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From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].
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Secondary outcome [4]
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Weight-adjusted Consumption of BAX 855 - Per Prophylactic Infusion and Pharmacokinetic (PK) Infusion
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Assessment method [4]
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Timepoint [4]
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Prophylactic Infusion: =50 exposure days or 6 months (±2 weeks), whichever occurs last. PK Infusion: PK #1 Pre-infusion within 30 minutes; Post-infusion 10 min, and 0.5, 1, 3, 6, 24, 32, 48, 56 hours (h). PK #2 also at Post-infusion 96h
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Secondary outcome [5]
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Weight-adjusted Consumption of BAX 855 - Per Treatment of Bleeding Episode (BE) and Per BE for Maintenance of Hemostasis
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Assessment method [5]
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Infusions per bleeding episode for maintenance of hemostasis only includes infusions following the resolution of a bleed to maintain hemostasis.
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Timepoint [5]
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Treatment of Bleeding Episode (BE): Minor/Moderate BE every 12 to 24 hours until bleeding is resolved; Major BE every 8 to 12 hours until bleeding is resolved. Per BE for Maintenance of Hemostasis: within 48 hours after bleeding episode resolution.
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Secondary outcome [6]
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Percentage of Participants With Adverse Events
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Assessment method [6]
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Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Timepoint [6]
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From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].
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Secondary outcome [7]
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Immunogenicity - Number of Participants With Positive Inhibitory Antibodies to FVIII, Binding Antibodies to FVIII, PEG-VIII, PEG and Anti-CHO Antibodies at Study Completion/Termination
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Assessment method [7]
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Number of participants who received BAX855, with immunogenicity data from study completion/termination visit. FVIII = factor VIII; PEG-VIII = polyethylene glycol-factor VIII; Anti-CHO = Anti-Chinese hamster ovary
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Timepoint [7]
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From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].
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Secondary outcome [8]
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Patient Reported Outcomes: Haemo-SYM Questionnaire, Change in Score From Baseline to End of Study
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Assessment method [8]
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The HAEMO-SYM has two subscales: pain and bleeds. HAEMO-SYM subscale scores are calculated by taking the mean of the items in each subscale and transforming them to a 0 (none or absent) to 100 (very severe) scale. Given that higher scores indicate more severe symptoms on the Haemo-SYM and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates an improvement (reduction in symptoms). Conversely, a positive change score indicates worsening symptoms.
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Timepoint [8]
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Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm].
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Secondary outcome [9]
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Patient Reported Outcomes - Short Form (SF)-36, Change From Baseline to End of Study
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Assessment method [9]
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Change from Baseline to End of Study for SF-36 Questionnaire is provided. Scores for individual SF-36 categories range from 0 to 100 with higher scores representing better health. Given that higher scores indicate better health-related quality of life (HRQoL) and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates a worsening of HRQoL.
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Timepoint [9]
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Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm]
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Secondary outcome [10]
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Pharmacokinetics (Pk) - Plasma Half-life (One-stage Clotting Assay)
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Assessment method [10]
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Terminal half-life calculated as log_e2/?z where ?z is the terminal elimination rate constant. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [10]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [11]
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Pharmacokinetics (Pk) - Mean Residence Time (One-stage Clotting Assay)
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Assessment method [11]
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The mean residence time (MRT) w as calculated as total area under the moment curve divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available). Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [11]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [12]
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Pharmacokinetics (Pk) - Total Body Clearance (One-stage Clotting Assay)
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Assessment method [12]
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Clearance in dL/(kg.h) will be calculated as the dose in IU/kg divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available). Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [12]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [13]
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Pharmacokinetics (Pk) - Incremental Recovery Over Time (One-stage Clotting Assay)
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Assessment method [13]
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Incremental recovery (IR) in (IU/dL)/ (IU/kg) calculated as: IR = (Cmax- (C pre-infusion)) / (Dose/kg), where C =concentration. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [13]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [14]
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Pharmacokinetics (Pk) - Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC0-8) (One-stage Clotting Assay)
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Assessment method [14]
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Calculated by WinNonlin NCA (Model 201, calculation method: Linear Trapezoidal Linear/Log Interpolation). Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [14]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [15]
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Pharmacokinetics (Pk) - Apparent Volume of Distribution at Steady State (Vss) (One-stage Clotting Assay)
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Assessment method [15]
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The apparent volume of distribution at steady state (Vss) will be calculated as: Vss = Clearance * Mean Residence Time. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [15]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [16]
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Pharmacokinetics (Pk) - Maximum Plasma Concentration (Cmax) (One-stage Clotting Assay)
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Assessment method [16]
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Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [16]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [17]
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Pharmacokinetics (Pk) -Time to Maximum Concentration in Plasma (Tmax) (One-stage Clotting Assay)
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Assessment method [17]
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Tmax in hours will be defined as the time to reach Cmax. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).
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Timepoint [17]
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Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).
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Secondary outcome [18]
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Change in Vital Signs From Screening - Temperature
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Assessment method [18]
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Timepoint [18]
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Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination
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Secondary outcome [19]
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Change in Vital Signs From Screening - Pulse Rate
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Assessment method [19]
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Timepoint [19]
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Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination
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Secondary outcome [20]
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Change in Vital Signs From Screening - Respiratory Rate
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Assessment method [20]
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Timepoint [20]
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Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination
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Secondary outcome [21]
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Changes in Vital Signs From Screening - Blood Pressure
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Assessment method [21]
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Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)
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Timepoint [21]
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Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination
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Secondary outcome [22]
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Changes in Clinical Chemistry Laboratory Assessments From Screening - Albumin and Protein
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Assessment method [22]
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Timepoint [22]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [23]
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Changes in Clinical Chemistry Laboratory Assessments From Screening - Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase
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Assessment method [23]
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Alkaline Phosphatase (Alk Phos); Alanine Aminotransferase (Ala Amino); Aspartate Aminotransferase (Asp Amino)
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Timepoint [23]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [24]
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Changes in Clinical Chemistry Laboratory Assessments From Screening - Bicarbonate, Chloride, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)
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Assessment method [24]
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0
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Timepoint [24]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [25]
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Changes in Clinical Chemistry Laboratory Assessments From Screening - Creatinine, and Bilirubin
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Assessment method [25]
0
0
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Timepoint [25]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [26]
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Changes in Hematology Laboratory Assessments From Screening - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
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Assessment method [26]
0
0
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Timepoint [26]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [27]
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Changes in Hematology Laboratory Assessments From Screening - Hematocrit
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Assessment method [27]
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0
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Timepoint [27]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [28]
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Changes in Hematology Laboratory Assessments From Screening - Hemoglobin
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Assessment method [28]
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0
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Timepoint [28]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [29]
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Changes in Hematology Laboratory Assessments From Screening - Erythrocytes
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Assessment method [29]
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0
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Timepoint [29]
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Screening, week 2, week 4, month 3, study completion/termination
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Secondary outcome [30]
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Changes in Lipid Panel Assessments From Screening - Cholesterol; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Triglycerides; and Very Low Density Lipoprotein (VLDL)
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Assessment method [30]
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0
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Timepoint [30]
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Screening, week 2, week 4, month 3, study completion/termination
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Eligibility
Key inclusion criteria
Main
- Participant and/or legal representative has/have voluntarily provided signed informed
consent
- Participant is 12 to 65 years old at the time of screening
- Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity <
1%) as confirmed by central laboratory at screening after the appropriate washout
period or a documented FVIII clotting activity <1%
- Participant has been previously treated with plasma-derived FVIII concentrates or
recombinant FVIII for =150 documented exposure days (EDs)
- Participant is currently receiving prophylaxis or on-demand therapy with FVIII
- Participant is willing and able to comply with the requirements of the protocol
Main
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Minimum age
12
Years
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Maximum age
65
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant has detectable FVIII inhibitory antibodies (= 0.6 Bethesda Units (BU)
using the Nijmegen modification of the Bethesda assay) as confirmed by central
laboratory at screening
- Participant has history of FVIII inhibitory antibodies (= 0.4 BU using the Nijmegen
modification of the Bethesda assay or = 0.6 BU using the Bethesda assay) at any time
prior to screening
- Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/07/2014
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Sample size
Target
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Accrual to date
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Final
159
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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The Alfred Hospital - Clayton
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Recruitment hospital [3]
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Fremantle Hospital - Fremantle
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Recruitment hospital [4]
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Hollywood Specialist Centre - Nedlands
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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6160 - Fremantle
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
Colorado
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kentucky
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Missouri
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Country [8]
0
0
United States of America
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State/province [8]
0
0
New York
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Country [9]
0
0
United States of America
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State/province [9]
0
0
North Carolina
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Ohio
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
0
0
South Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Utah
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Washington
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Country [15]
0
0
Austria
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State/province [15]
0
0
Linz
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Country [16]
0
0
Austria
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State/province [16]
0
0
Vienna
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Country [17]
0
0
Bulgaria
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State/province [17]
0
0
Sofia
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Country [18]
0
0
Czechia
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State/province [18]
0
0
Brno
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Country [19]
0
0
Czechia
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State/province [19]
0
0
Olomouc
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Country [20]
0
0
Czechia
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State/province [20]
0
0
Praha 5
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Country [21]
0
0
Germany
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State/province [21]
0
0
Nordrhein Westfalen
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Country [22]
0
0
Germany
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State/province [22]
0
0
Berlin
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Country [23]
0
0
Germany
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State/province [23]
0
0
Hamburg
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Country [24]
0
0
Germany
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State/province [24]
0
0
Hannover
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Country [25]
0
0
Israel
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State/province [25]
0
0
Haifa
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Country [26]
0
0
Israel
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State/province [26]
0
0
Tel Aviv
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Country [27]
0
0
Japan
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State/province [27]
0
0
Aichi-Ken
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Country [28]
0
0
Japan
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State/province [28]
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Fukuoka-Ken
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Japan
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Japan
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Japan
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Kanagawa-Ken
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Japan
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Japan
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Busan
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Daejeon
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Seoul
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Ulsan
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Lithuania
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Vilnius
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Malaysia
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Pulau Pinang
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Selangor
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Kuala Lumpur
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Netherlands
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Amsterdam
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Gdansk
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Lodz
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Romania
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Bucuresti
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Baleares
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Spain
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La Coruña
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Málaga
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Valencia
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Ukraine
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Donetsk
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Ukraine
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Lviv
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United Kingdom
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Avon
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Leicestershire
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United Kingdom
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Oxfordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Baxalta now part of Shire
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Ethics approval
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Summary
Brief summary
To assess efficacy and safety, including immunogenicity of BAX 855 administered as
prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated
patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of
BAX 855.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01736475
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Contacts
Principal investigator
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Study Director
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Takeda
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01736475
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