Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

Conditions
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Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
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* Drug: turoctocog alfa pegol


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br> | Drug: turoctocog alfa pegol<br>* Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.<br>* Other names: NNC 0129-0000-1003;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Assessed by the Investigator/surgeon at the day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Consumption of N8-GP During Surgery | Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'. | During surgery, defined as the time from knife to skin until last stitch | 
| Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6 | 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. | During the post-operative period, days 1-6 | 
| Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14 | 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. | During the post-operative period, days 7-14 | 
| Average Consumption of N8-GP During the Post-operative Period Days 1-6 | 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. | During the post-operative period, days 1-6 | 
| Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL) | 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. | during the trial (2-5 weeks) | 
| Estimated Blood Loss During Surgery | The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery. | During surgery | 
| Number of Transfusions During the Post-operative Period Days 1-6 | Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented. | Post-operative period, days 1-6 | 
| Length of Stay in the Hospital | Mean number of days stayed at the hospital during the trial. | During the trial (2-5 weeks) | 
| Number of Days in Intensive Care | Mean number of days in the intensive care due to surgery during the trial is presented. | During the trial (2-5 weeks) | 
| Adverse Events Reported During the Trial Period | 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). | During the trial (2-5 weeks) | 
| Serious Adverse Events Reported During the Trial Period | 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). | During the trial (2-5 weeks) |