Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 1

Conditions: Von Willebrand's Disease

Treatments: Drug: von Willebrand factor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004667

199/11955

UNCCH-826

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

• von Willebrand's disease