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

Von Willebrand's Disease Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Von Willebrand Diseases
• Von Willebrand's Disease

• NCT number: NCT00004667
• Study type: Interventional
• Source: Office of Rare Diseases (ORD)
• Status: Completed
• Phase: Phase 1
• Start date: October 1993