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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00168090
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: CSL Behring
• Public title: Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
• Scientific 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.
• Date of first enrolment: October 2001
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00168090
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Marylin J. Manco-Johnson, M.D.
• Affiliation: Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hematologic Disease

Blood Coagulation Disorders

Blood Platelet Disorders

Von Willebrand Disease

Intervention(s)

Drug: Blood coagulation Factor VIII and vWF, human

Primary Outcome(s)

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(s)

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

Secondary ID(s)

AP7000/1-4002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors