A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
Phase 2
Completed
- Conditions
- vonWillebrand's Disease
- Registration Number
- NCT02250508
- Lead Sponsor
- Bio Products Laboratory
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC (0-48h) for VWF: RCo Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hematology Dept., Sackler School of Medicine, Tel Aviv University
🇮🇱Tel Aviv, Israel
Hematology Dept., Sackler School of Medicine, Tel Aviv University🇮🇱Tel Aviv, Israel