An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
NCT02246868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2018-02-15
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 treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.
Conditions
- Haemophilia A
Interventions
- BIOLOGICAL
-
Optivate® (Human Coagulation Factor VIII)
Sponsors & Collaborators
-
Bio Products Laboratory
lead OTHER
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-09-30
- Primary Completion
- 2004-08-31
Countries
- Poland
- United Kingdom
Study Locations
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