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

NCT00168090 | Completed Phase 4

• 1 other identifier: AP7000/1-4002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Von Willebrand Disease; Blood Coagulation Disorders; Blood Platelet Disorders; Hematologic Disease

Keywords

von Willebrand Factor; Blood Coagulation Disorders; Factor VIII

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Blood coagulation Factor VIII and vWF, human DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (1)

Unknown Facility

Milwaukee, Wisconsin, 53201-2178, United States

Location

Related Links

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MeSH Terms

Conditions

von Willebrand Diseases; Blood Coagulation Disorders; Blood Platelet Disorders; Hematologic Diseases; Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Marylin J. Manco-Johnson, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: October 1, 2001
• Study Completion: May 1, 2006
• Last Updated: February 11, 2011

Record last verified: 2011-02

Locations

US (1)