NL-OMON42941CompletedNot Applicable
A multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A - pathfinder*7
ovo Nordisk0 sites2 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.;2. Ongoing participation in pathfinder*2 (NN7088-3859);3. Male, age * 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
Exclusion Criteria
- •1. FVIII inhibitors (*0.6 BU) at last visit in pathfinder*2 prior to entry in pathfinder*7;2. Planned surgery during the trial;3. Major surgery performed within 4 weeks prior to screening;4. Previous participation in this trial. Participation is defined as signed informed consent;5. Any disorder, except for conditions associated with haemophilia A, which in the investigator*s opinion might jeopardise patient*s safety or compliance with the protocol
Investigators
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