vonWillebrand's Disease Clinical Trial
Official title:
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.
| NCT number | NCT02250508 |
| Other study ID # | 8VWF04 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | September 2, 2014 |
| Last updated | February 14, 2018 |
| Start date | December 2004 |
| Verified date | February 2018 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | June 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hematology Dept., Sackler School of Medicine, Tel Aviv University | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUC (0-48h) for VWF: RCo | Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose |