Trials / Completed
CompletedNCT02246881
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and 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
- —
Summary
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Optivate® (Human Coagulation Factor VIII) |
Timeline
- Start date
- 2001-10-01
- Primary completion
- 2004-01-01
- First posted
- 2014-09-23
- Last updated
- 2018-02-15
Locations
8 sites across 2 countries: Poland, United Kingdom
Source: ClinicalTrials.gov record NCT02246881. Inclusion in this directory is not an endorsement.