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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01489111
Registration number
NCT01489111
Ethics application status
Date submitted
23/11/2011
Date registered
9/12/2011
Date last updated
10/08/2020
Titles & IDs
Public title
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
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Scientific title
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
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Secondary ID [1]
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U1111-1119-7326
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Secondary ID [2]
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NN7088-3860
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Universal Trial Number (UTN)
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Trial acronym
pathfinder™3
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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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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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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
Treatment: Drugs - turoctocog alfa pegol
Experimental: Surgery -
Treatment: Drugs: turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
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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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Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None
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Assessment method [1]
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Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as "last stitch").
Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
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Timepoint [1]
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Assessed by the Investigator/surgeon at the day of surgery
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Secondary outcome [1]
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Average Consumption of N8-GP During Surgery
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Assessment method [1]
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Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'.
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Timepoint [1]
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During surgery, defined as the time from "knife to skin" until "last stitch"
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Secondary outcome [2]
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Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6
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Assessment method [2]
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Haemostatic effect during post-operative period days 1-6 as evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.
Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
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Timepoint [2]
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During the post-operative period, days 1-6
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Secondary outcome [3]
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Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14
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Assessment method [3]
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Haemostatic effect during post-operative period days 1-6 and days 7-14 was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.
Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
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Timepoint [3]
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During the post-operative period, days 7-14
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Secondary outcome [4]
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Average Consumption of N8-GP During the Post-operative Period Days 1-6
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Assessment method [4]
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Average consumption of N8-GP during post operative period days 1-6 is presented. Analysis population: Full analysis set included all subjects exposed to the trial drug (N8-GP) and completed surgery.
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Timepoint [4]
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During the post-operative period, days 1-6
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Secondary outcome [5]
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Incidence Rate of Inhibitors Against Factor VIII (FVIII) (=0.6 BU/mL)
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Assessment method [5]
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Incidence rate of inhibitors is the number of newly developed inhibitors per surgery. Development of FVIII inhibitors was measured by a validated Nijmegen modified Bethesda assay. A positive inhibitor test was defined as =0.6 bethesda unit. Number of participants with inhibitors at the end of trial is presented.
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Timepoint [5]
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during the trial (2-5 weeks)
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Secondary outcome [6]
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Estimated Blood Loss During Surgery
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Assessment method [6]
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The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.
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Timepoint [6]
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During surgery
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Secondary outcome [7]
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Number of Transfusions During the Post-operative Period Days 1-6
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Assessment method [7]
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Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented.
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Timepoint [7]
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Post-operative period, days 1-6
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Secondary outcome [8]
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Length of Stay in the Hospital
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Assessment method [8]
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Mean number of days stayed at the hospital during the trial.
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Timepoint [8]
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During the trial (2-5 weeks)
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Secondary outcome [9]
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Number of Days in Intensive Care
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Assessment method [9]
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Mean number of days in the intensive care due to surgery during the trial is presented.
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Timepoint [9]
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During the trial (2-5 weeks)
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Secondary outcome [10]
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Adverse Events Reported During the Trial Period
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Assessment method [10]
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Number of adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).
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Timepoint [10]
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During the trial (2-5 weeks)
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Secondary outcome [11]
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Serious Adverse Events Reported During the Trial Period
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Assessment method [11]
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Number of serious adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).
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Timepoint [11]
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During the trial (2-5 weeks)
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Eligibility
Key inclusion criteria
* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
* Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
* The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
* Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
* The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
* FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
* Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Immune modulating or chemotherapeutic medication
* Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
* Unwillingness, language or other barriers precluding adequate understanding and/or cooperation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
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
3/08/2012
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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
10/12/2018
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Sample size
Target
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Camperdown
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - South Brisbane
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Kashihara-shi, Nara
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Japan
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Shinjuku-ku, Tokyo
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Suginami-ku, Tokyo
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Samsun
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Basingstoke
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Cardiff
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London
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Oxford
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United Kingdom
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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 this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
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Trial website
https://clinicaltrials.gov/study/NCT01489111
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Trial related presentations / publications
Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.
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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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Phone
0
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Fax
0
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Email
0
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Contact person for public queries
Name
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT01489111/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT01489111/Prot_SAP_000.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT01489111
Download to PDF