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

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).

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.

Conditions

Hemophilia A

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Assessment of hemostatic efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale

Secondary Outcome Measures:

• Efficacy endpoints:
  • Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital
  • Capture Total Consumption of ReFacto AF and Consumption per bleeding event
  • Capture the number of bleeding episodes and response to treatment
  • Assess the pharmacokinetics of ReFacto AF in the patient population
  • Assess the incidence of less than expected therapeutic effect
  • Comparison of the predicted and actual estimated blood loss and transfusion requirements
  • Monitor the types of continuous infusion regimens and comparison of planned regimens versus regimens actually used
  • Assess patient compliance with prescribed outpatient
• Safety endpoints:
  • Adverse events
  • Incidence of Factor VIII inhibitor development, thrombosis
  • Incidence of allergic reactions in the patient population

Study Start

December 2005

Eligibility & Criteria

• Ages Eligible for Study: 12 Years and above
• Genders Eligible for Study: Male

Inclusion 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

Total Enrolment

50

Contact Details

Perth, Australia; Recruiting

• Email: clintrialparticipation@wyeth.com
• Please refer to this study by ClinicalTrials.gov identifier NCT00243659