Study Evaluating ReFacto AF in Severe Hemophilia A

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)

• Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product

• Age greater than or equal to 12 years

• History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study

• Adequate laboratory results

Exclusion Criteria:

• Presence of any bleeding disorder in addition to hemophilia A

• Concomitant therapy with immunosuppressive drugs

• Current or historical Factor VIII inhibitor

• Treatment with any investigational drug or device within the past 30 days