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	Drug: ReFacto AF	Phase III

Further study details as provided by Wyeth:

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  50

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  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

Please refer to this study by ClinicalTrials.gov identifier  NCT00243659

Trial Manager       clinicaltrialinfo@wyeth.com

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

Study ID Numbers:  3082B2-311
Last Updated:  January 5, 2006
Record first received:  October 20, 2005
ClinicalTrials.gov Identifier:  NCT00243659
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10