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

Phase 3

Completed

• Conditions: Hemophilia A
• Interventions: Biological: ReFacto AF

• Registration Number: NCT00243659
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-20
• Study First Submitted QC: 2005-10-20
• Study First Posted: 2005-10-24
• Study Start: 2006-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-05-29
• Results First Submitted QC: 2009-05-29
• Results First Posted: 2009-07-20
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-02
• Last Update Posted: 2011-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	ReFacto AF	-
A	ReFacto AF	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Achieved Hemostatic Efficacy After Surgery	6 weeks	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

Name	Time	Method
Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge	6 weeks	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.