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Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00243659
First received: October 20, 2005
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
  Purpose

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).


Condition Intervention Phase
Hemophilia A
 Biological: ReFacto AF
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Patients Who Achieved Hemostatic Efficacy After Surgery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.


Secondary Outcome Measures:
  • Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.


Enrollment: 30
Study Start Date: April 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: ReFacto AF
Experimental: B Biological: ReFacto AF

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
  • Previously treated with at least 150 exposure days to any Factor VIII product
  • Normal hepatic and renal function tests and no other bleeding disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243659

Locations
United States, California
LaJolla, California, United States, 92093
United States, Michigan
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Pittsburg, Pennsylvania, United States, 15213
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Charlottesville, Virginia, United States, 22908
Australia
Perth, Australia
Austria
Vienna, Austria
Hungary
Budapest, Hungary
New Zealand
Auckland, New Zealand
Chirstchurch, New Zealand
Poland
Warsawa, Poland
Romania
Bucurest, Romania
Sweden
Malmö, Sweden
Stockholm, Sweden
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00243659     History of Changes
Other Study ID Numbers: 3082B2-311
Study First Received: October 20, 2005
Results First Received: May 29, 2009
Last Updated: June 2, 2011
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hemophilia A
bleeding disorder

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013