Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Male patients greater than or equal to 12 years of age with severe hemophilia A (FVIII:C less than 1%).

• Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII replacement products.

• Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.

• Serum albumin greater than or equal to the lower limit of normal (LLN).

• Platelet count greater than or equal to 100,000/µL.

• Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized ratio (INR) less than or equal to 1.5.

• HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load less than 200 particles/µL.

Exclusion Criteria:

• Presence of any bleeding disorder in addition to hemophilia A.

• A positive FVIII inhibitor, according to the local laboratory, at screening; or any Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the testing laboratory.

• Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.

• Prior exposure to moroctocog alfa (AF-CC).

• Known hypersensitivity to hamster protein.