Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)

This study has been completed.

First Received on September 12, 2005. Last Updated on February 10, 2011 History of Changes

Sponsor:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00168090

Purpose

The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.

Condition	Intervention	Phase
Von Willebrand Disease Blood Coagulation Disorders Blood Platelet Disorders Hematologic Disease	Drug: Blood coagulation Factor VIII and vWF, human	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia MYH9-related disorder von Willebrand disease Help Me Understand Genetics

MedlinePlus related topics: Bleeding Disorders Hemophilia Platelet Disorders

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

Further study details as provided by CSL Behring:

Primary Outcome Measures:

To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.

Secondary Outcome Measures:

To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.

Estimated Enrollment:	30
Study Start Date:	October 2001
Estimated Study Completion Date:	May 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Subjects of any age
Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP
Require substitution with vWF/FVIII complex due to a surgery

Key Exclusion Criteria:

Known significant hemostatic disorder other than vWD
Acquired vWD
Known antibodies to FVIII or vWF
Known platelet type vWD
Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol
History of allergic reaction to Humate-P®
Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents)
Progressive fatal disease/life expectancy of less than 6 months
Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment
Pediatric patients of insufficient body weight to permit PK sampling
Woman in the first 20 weeks of pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168090

Locations

United States, Wisconsin

Milwaukee, Wisconsin, United States, 53201-2178

Sponsors and Collaborators

CSL Behring

Investigators

Principal Investigator:

Marylin J. Manco-Johnson, M.D.

Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.

More Information

Additional Information:

Click here for more information about this study. This link exits the ClinicalTrials.gov site

Click here to request more information about this study This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00168090 History of Changes
Other Study ID Numbers:	AP7000/1-4002
Study First Received:	September 12, 2005
Last Updated:	February 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by CSL Behring:

von Willebrand Factor
Blood Coagulation Disorders
Factor VIII

Additional relevant MeSH terms:

Blood Coagulation Disorders
Hemostatic Disorders
Blood Platelet Disorders
Hemophilia A
Hematologic Diseases
Von Willebrand Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012