Study Evaluating ReFacto AF in Severe Hemophilia A

Phase 3

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00037544
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-05-17
• Study First Submitted QC: 2002-05-17
• Study First Posted: 2002-05-20
• Primary Completion: 2004-08
• Study Completion: 2004-08
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified