Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
Phase 1
Completed
- Conditions
- Von Willebrand's Disease
- Registration Number
- NCT00004667
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief Summary
OBJECTIVES: I. Evaluate the effect of a new von Willebrand factor concentrate on bleeding time, in vivo recovery, and circulating half-life of the infused factor in patients with von Willebrand's disease.
II. Assess the safety of von Willebrand factor in these patients.
- Detailed Description
PROTOCOL OUTLINE: Patients receive 1 dose of von Willebrand factor concentrate. Timed blood studies are performed for the next 96 hours.
Patients are followed every 2 weeks for 16 weeks, and at 24, 36, and 52 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method