Trials / Completed
CompletedNCT00816660
Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease
Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex (rVWF:rFVIII): A Phase 1 Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability in Type 3 Von Willebrand Disease (VWD)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to evaluate the immediate tolerability and safety of rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various dosages of VWF:RCo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII) | Single dose, dose escalation, various cohorts |
| BIOLOGICAL | Marketed plasma-derived VWF/FVIII concentrate | Cross-over: recombinant FVIII (rVWF:rFVIII) and marketed plasma-derived VWF/FVIII concentrate |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-08-31
- Completion
- 2010-08-31
- First posted
- 2009-01-05
- Last updated
- 2021-05-03
Locations
25 sites across 6 countries: United States, Austria, Canada, Germany, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT00816660. Inclusion in this directory is not an endorsement.