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

• ClinicalTrials.gov Identifier: NCT00243659
• Recruitment Status: Completed
• First Posted: October 24, 2005
• Results First Posted: July 20, 2009
• Last Update Posted: June 3, 2011
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: October 20, 2005
• First Posted Date: October 24, 2005
• Results First Submitted Date: May 29, 2009
• Results First Posted Date: July 20, 2009
• Last Update Posted Date: June 3, 2011
• Study Start Date: April 2006
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2010)

Number of Patients Who Achieved Hemostatic Efficacy After Surgery [ Time Frame: 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.

Original Primary Outcome Measures (submitted: October 20, 2005)

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

Current Secondary Outcome Measures (submitted: April 22, 2010)

Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: October 20, 2005)

• 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 and
• allergic reactions in the patient population

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hemophilia A
• Intervention: Biological: ReFacto AF

Study Arms

• Experimental: A
  Intervention: Biological: ReFacto AF
• Experimental: B
  Intervention: Biological: ReFacto AF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 29, 2009): 30
• Original Enrollment (submitted: October 20, 2005): 50
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Hungary, New Zealand, Poland, Romania, Sweden, United States

Administrative Information

• NCT Number: NCT00243659
• Other Study ID Numbers: 3082B2-311
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: June 2011