Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) (NCT00168090)

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Study 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.

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Conditions studied

Von Willebrand Disease
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Disease

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Keywords

von Willebrand Factor
Blood Coagulation Disorders
Factor VIII

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In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's enrollment of 30 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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

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Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants

Interventions

DrugBlood coagulation Factor VIII and vWF, human

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What researchers measure

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.

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Study locations

1 site

Milwaukee, Wisconsin 53201-2178, United States

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References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT00168090
Lead sponsor: CSL Behring
First posted: Sep 14, 2005
Start date: Oct 2001
Completion: May 2006
Last update: Feb 11, 2011

Study contacts

Marylin J. Manco-Johnson, M.D.

principal investigator · Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.

View the source record on ClinicalTrials.gov ↗

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