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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of North Carolina
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004667

Purpose

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.

Condition	Intervention	Phase
Von Willebrand's Disease	Drug: von Willebrand factor	Phase I

Genetics Home Reference related topics: hemophilia von Willebrand disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	10
Study Start Date:	October 1993

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA: - von Willebrand's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004667

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of North Carolina

Investigators

Study Chair:

Gilbert C. White

University of North Carolina

More Information

Publications:

Menache D, Aronson DL, Darr F, Montgomery RR, Gill JC, Kessler CM, Lusher JM, Phatak PD, Shapiro AD, Thompson AR, White GC 2nd. Pharmacokinetics of von Willebrand factor and factor VIIIC in patients with severe von Willebrand disease (type 3 VWD): estimation of the rate of factor VIIIC synthesis. Cooperative Study Groups. Br J Haematol. 1996 Sep;94(4):740-5.

Study ID Numbers:	199/11955, UNCCH-826
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004667 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

hematologic disorders
rare disease
von Willebrand's disease

Study placed in the following topic categories:

Von Willebrand Disease
Thrombocytopathy
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Platelet Disorders
Blood Coagulation Disorders
Rare Diseases
Hemostatic Disorders

Additional relevant MeSH terms:

Von Willebrand Disease
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn

Coagulation Protein Disorders
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders

ClinicalTrials.gov processed this record on May 07, 2009