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

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.

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Key information

Conditions

Von Willebrand Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders von Willebrand Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Milwaukee, Wisconsin, 53201-2178, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood coagulation Factor VIII and vWF, human

Drug

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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.

Important dates

Study start: 2001
Study completion: 2006
First posted: Sep 14, 2005
Registry last updated: Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed