Safety Surveillance Study of Patients switching to ReFacto AF.
Research type
Research Study
Full title
A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF from ReFacto or other Factor VIII Products in Usual Care Settings.
IRAS ID
16018
Sponsor organisation
Wyeth Research Division of Wyeth Pharmaceuticals Inc
Eudract number
2008-007997-39
Clinicaltrials.gov Identifier
Research summary
This study will focus on monitoring the development of clinically significant and laboratory-confirmed inhibitors in a population of patients with hemophilia A switching to ReFacto AF from ReFacto or other FVIII products. This is in accordance with current EMEA/CHMP guidelines and recommendations. A recombinant (genetically engineered and not made from human plasma) human factor VIII, moroctocog alfa (AF-CC) or "ReFacto AFR" is an approved drug for the treatment of hemophilia A. ReFacto AF is very similar to factor VIII produced in the body, and may increase the levels of factor VIII in the blood and improve the body's ability to clot blood and control bleeding in people with hemophilia A. ReFacto AF is made without adding human or animal proteins, which may lower the risk of viral contamination. The study will require diagnostic testing for inhibitor surveillance at a frequency consistent with commonly accepted standard of care practice in the usual clinical setting after a patient's transition to a new replacement therapy. Patients will be monitored in the usual care setting while following treatment practice recommendations of their prescribing physician. All male patients greater than or equal to 12 years of age with severe hemophilia A transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII products will be eligible to enroll.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
09/H0402/40
Date of REC Opinion
30 Apr 2009
REC opinion
Further Information Favourable Opinion