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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.
Information provided by:
CSL Behring Identifier:
First received: September 12, 2005
Last updated: February 10, 2011
Last verified: February 2011
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00168090

United States, Wisconsin
Milwaukee, Wisconsin, United States, 53201-2178
Sponsors and Collaborators
CSL Behring
Principal Investigator: Marylin J. Manco-Johnson, M.D. Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.
  More Information

Additional Information: Identifier: NCT00168090     History of Changes
Other Study ID Numbers: AP7000/1-4002
Study First Received: September 12, 2005
Last Updated: February 10, 2011

Keywords provided by CSL Behring:
von Willebrand Factor
Blood Coagulation Disorders
Factor VIII

Additional relevant MeSH terms:
Hematologic Diseases
Von Willebrand Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Blood Platelet Disorders
Hemophilia A
Pathologic Processes
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants processed this record on September 20, 2017