Trials / Completed
CompletedNCT02246868
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Optivate® (Human Coagulation Factor VIII) |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2004-08-01
- First posted
- 2014-09-23
- Last updated
- 2018-02-15
Locations
11 sites across 2 countries: Poland, United Kingdom
Source: ClinicalTrials.gov record NCT02246868. Inclusion in this directory is not an endorsement.