Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

Phase 3

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00038935
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-18
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER