Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

• 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 < 1% at local laboratory)

• Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product

• Age greater than or equal to 12 years\

Exclusion Criteria:

• The presence of any bleeding disorder in addition to hemophilia A

• Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)

• History of detectable factor VIII inhibitor