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

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CSL Behring

Status and phase

Completed
Phase 4

Conditions

Von Willebrand Disease
Hematologic Disease
Blood Platelet Disorders
Blood Coagulation Disorders

Treatments

Drug: Blood coagulation Factor VIII and vWF, human

Study type

Interventional

Funder types

Industry

Identifiers

NCT00168090
AP7000/1-4002

Details and patient eligibility

About

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.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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