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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.
Sponsor:
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168090
First received: September 12, 2005
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  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 4

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:

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
Hematologic Diseases
Von Willebrand Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
 Coagulation Protein Disorders
Genetic Diseases, Inborn
Hemophilia A
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013