A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
NCT02246894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2018-02-15
Summary
The main objectives of this study are:
* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.
Conditions
- Haemophilia A
Interventions
- BIOLOGICAL
-
Optivate® (Human Coagulation Factor VIII)
Sponsors & Collaborators
-
Bio Products Laboratory
lead OTHER
Eligibility
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-11-30
- Primary Completion
- 2005-01-31
Countries
- Poland
Study Locations
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