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

Phase 4

Completed

• Conditions: Blood Coagulation Disorders; Blood Platelet Disorders; Hematologic Disease; Von Willebrand Disease

• Registration Number: NCT00168090
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Study Completion: 2006-05
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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