Trials / Completed
CompletedNCT02246894
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Optivate® (Human Coagulation Factor VIII) |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2005-01-01
- First posted
- 2014-09-23
- Last updated
- 2018-02-15
Locations
5 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT02246894. Inclusion in this directory is not an endorsement.