Trials / Completed
CompletedNCT02250508
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The main objectives of the study were * to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays. * to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Optivate® (Human Coagulation Factor VIII) | |
| BIOLOGICAL | Haemate P® (Human Coagulation Factor VIII) |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2005-06-01
- First posted
- 2014-09-26
- Last updated
- 2018-02-15
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT02250508. Inclusion in this directory is not an endorsement.