A research study looking at how a factor VIII medicine called turoctocog alfa pegol (N8-GP) works in people with haemophilia A

Phase 1

• Conditions: Haemophilia A; MedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-003788-36-IT
• Lead Sponsor: OVO NORDISK. S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-03
• Study Start: 2021-05-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

1. Male patients of all ages with the diagnosis of severe congenital haemophilia A (FVIII activity <1%) based on medical records
2. On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of transfer
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
2. Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol
3. Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.;Secondary Objective: To investigate the following in severe haemophilia A patients previously treated with turoctocog alfa pegol<br>1. Development of FVIII inhibitors<br>2. Efficacy of turoctocog alfa pegol prophylaxis<br>3. Haemostatic efficacy of turoctocog alfa pegol when used for treatment of bleeds;Primary end point(s): Number of adverse events reported;Timepoint(s) of evaluation of this end point: Week 0 to week 104

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence of FVIII inhibitors > or = 0.6 BU<br>2. Number of bleeding episodes on prophylaxis<br>3. Number of spontaneous bleeding episodes on prophylaxis<br>4. Haemostatic effect of turoctocog alfa pegol when used for treatment<br>of bleeding episodes assessed as: Excellent, Good, Moderate, or None<br>5. Number of turoctocog alfa pegol injections required per bleeding episode;Timepoint(s) of evaluation of this end point: 1- 5: After 104 weeks