Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease

• Conditions: Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD.; MedDRA version: 7.1Level: LLTClassification code 10047715

• Registration Number: EUCTR2004-004868-69-AT
• Lead Sponsor: ZLB Behring LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-31
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Subjects of any age
Clinical and laboratory diagnosis of VWD (VWF:RCo level of <35 IU/dL or VWF:RCo level of <50 IU/dL and a family and/or personal history consistent with VWD) that can be expected to respond to exogenously administered von Willebrand factor, or Type IIN VWD
Can not be expected to show a hemostatic response to desmopressin acetate (DDAVP) sufficient to control bleeding throughout surgery, as judged by the investigator
Require substitution with VWF/FVIII complex due to a surgery
Expectation of at least 2 consecutive days of post-operative treatment with Humate-P®
Informed written consent has been obtained (for pediatric subjects - signed by his/her legal guardian, representative with subject assent as appropriate)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
Subject/family judged unable to comply with study protocol and requirements
Currently taking concomitant therapies listed in Section 5.3 of the study protocol
Pediatric subjects of insufficient body weight to permit PK sampling
Woman in the first 20 weeks of pregnancy
Subjects who were previously enrolled and completed this study may not be re-enrolled

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified