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

Condition(s) targeted: Hemophilia A

Intervention: ReFacto AF (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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

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

Primary outcome: 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:

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;

Adverse events

Incidence of Factor VIII inhibitor development, thrombosis and allergic reactions in the patient population

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Male.

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

Trial Manager, Email: clintrialparticipation@wyeth.com

Perth, Australia; Recruiting
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Vienna, Austria; Recruiting
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Budapest, Hungary; Recruiting
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Auckland, New Zealand; Recruiting
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Chirstchurch, New Zealand; Recruiting
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Warsawa, Poland; Recruiting
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Bucurest, Romania; Recruiting
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Stockholm, Sweden; Recruiting
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Malmö, Sweden; Recruiting
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LaJolla, California 92093, United States; Recruiting
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Detroit, Michigan 48201, United States; Recruiting
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Detroit, Michigan 48202, United States; Recruiting
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Chapel Hill, North Carolina 27599, United States; Recruiting
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Pittsburg, Pennsylvania 15213, United States; Recruiting
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Hershey, Pennsylvania 17033, United States; Recruiting
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Houston, Texas 77030, United States; Recruiting
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Charlottesville, Virginia 22908, United States; Recruiting
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Starting date: December 2005
Ending date: March 2009
Last updated: December 19, 2007