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

Blood Coagulation Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168090
• Other study ID #: AP7000/1-4002
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 10, 2011
• Start date: October 2001
• Est. completion date: May 2006

Study information

• Verified date: February 2011
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Platelet Disorders
• Disease
• Hematologic Disease
• Hematologic Diseases
• Hemophilia A
• Hemostatic Disorders
• Von Willebrand Disease
• Von Willebrand Diseases

Intervention

Drug:
• Blood coagulation Factor VIII and vWF, human

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.

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