Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients with Severe Haemophilia A

Phase 3

Completed

Conditions: blood clothing disorder
Haemophilia A
10064477

Registration Number: NL-OMON46773

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

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

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 nonapproved investigational medicinal product

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Number of adverse events reported</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary endpoints:<br /><br>* Incidence of FVIII inhibitors 0.6 BU<br /><br> Number of bleeding episodes on prophylaxis<br /><br>* Number of spontaneous bleeding episodes on prophylaxis<br /><br>* Haemostatic effect of turoctocog alfa pegol when used for treatment of<br /><br>bleeding episodes assessed as: Excellent, Good, Moderate, or None<br /><br>* Number of turoctocog alfa pegol injections required per bleeding episode</p><br>