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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168090

Enrollment

Registered

2005-09-14

Start date

2001-10-31

Completion date

2006-05-31

Last updated

2011-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Disease, Von Willebrand Disease

Keywords

von Willebrand Factor, Blood Coagulation Disorders, Factor VIII

Brief 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.

Interventions

DRUGBlood coagulation Factor VIII and vWF, human

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026