Status:
COMPLETED
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Lead Sponsor:
Bio Products Laboratory
Conditions:
Haemophilia A
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when ...
Eligibility Criteria
Inclusion
- Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.
Exclusion
- \-
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02246868
Start Date
September 1 2001
Last Update
February 15 2018
Active Locations (11)
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1
Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.
Bialystok, Poland
2
Klinika Haematologii, Akademia Medyczna w Gdansku, u.
Gdansk, Poland
3
Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
Lodz, Poland
4
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
Lublin, Poland