EUCTR2017-003788-36-GBActive, not recruitingPhase 1
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 - pathfinder8
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 170
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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: 60
- •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
Investigators
Similar Trials
Active, not recruiting
Phase 1
A research study looking at how a factor VIII medicine called turoctocog alfa pegol (N8-GP) works in people with haemophilia AHaemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2017-003788-36-HUovo Nordisk A/S170
Active, not recruiting
Phase 1
Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Previously Untreated Patients with Haemophilia AHaemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2013-004025-88-GRovo Nordisk A/S125
Active, not recruiting
Phase 1
A research study looking at how a factor VIII medicine called turoctocog alfa pegol (N8-GP) works in people with haemophilia AHaemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2017-003788-36-DEovo Nordisk A/S170
Active, not recruiting
Phase 1
A research study looking at how a factor VIII medicine called turoctocog alfa pegol (N8-GP) works in people with haemophilia AHaemophilia AMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2017-003788-36-HRovo Nordisk A/S170
Active, not recruiting
Phase 1
Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Previously Untreated Patients with Haemophilia AHaemophilia AMedDRA version: 17.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2013-004025-88-ROovo Nordisk A/S125