Status:
TERMINATED
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
Lead Sponsor:
Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE4
Brief Summary
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.
Detailed Description
The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy conce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00884390
Start Date
May 1 2009
End Date
March 1 2013
Last Update
September 1 2014
Active Locations (74)
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1
Pfizer Investigational Site
Vienna, Austria, 1090
2
Pfizer Investigational Site
Brussels, Belgium, Belgium, 1200
3
Pfizer Investigational Site
Brussels, Belgium, 1020
4
Pfizer Investigational Site
Leuven, Belgium, 3000