NCT00168090CompletedPhase 4
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- CSL Behring
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Outcomes
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.
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for InjectionHemophilia ANCT00952822Baxalta now part of Shire52
Active, not recruiting
Not Applicable
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 DiseaseVon 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 10047715EUCTR2004-004868-69-ATZLB Behring LLC30
Active, not recruiting
Not Applicable
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 DiseaseVon 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 10047715EUCTR2004-004868-69-SEZLB Behring LLC30
Completed
Phase 2
Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing SurgeryHemophilia ANCT00157105Baxalta now part of Shire59
Completed
Phase 2
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia AHemophilia ANCT00157040Baxalta now part of Shire50