- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168090
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
February 10, 2011 updated by: CSL Behring
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53201-2178
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marylin J. Manco-Johnson, M.D., Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Study Completion
May 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
February 11, 2011
Last Update Submitted That Met QC Criteria
February 10, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Blood Coagulation Disorders, Inherited
- Coagulation Protein Disorders
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Hemostatic Disorders
- Hemophilia A
- Blood Coagulation Disorders
- Disease
- Hematologic Diseases
- Von Willebrand Diseases
- Blood Platelet Disorders
- Coagulants
- Factor VIII
Other Study ID Numbers
- AP7000/1-4002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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