Phase III AFFINE study of giroctocogene fitelparvovec for hemophilia A, has re-opened recruitment
Pfizer and Sangamo Therapeutics announced that the Phase III AFFINE study evaluating giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A, has re-opened recruitment
Trial sites will begin to resume enrollment this month, with dosing expected to resume in October. All trial sites are anticipated to be active by the end of 2022 and a pivotal readout is expected in the first half of 2024.
About the AFFINE study: The Phase III AFFINE (NCT04370054) study is an open-label, multicenter, single arm study to evaluate the efficacy and safety of a single infusion of giroctocogene fitelparvovec in more than 60 adult (ages 18-64 years) male participants with moderately severe to severe hemophilia A. Eligible study participants will have completed at least six months of routine FVIII prophylaxis therapy during the lead-in Phase III study (NCT03587116) in order to collect pretreatment data for efficacy and selected safety parameters.The primary endpoint is impact on annualized bleeding rate (ABR) through 15 months following treatment with giroctocogene fitelparvovec. This will be compared to ABR on prior FVIII prophylaxis replacement therapy. The secondary endpoints include FVIII activity level after the onset of steady state and through 15 months following infusion of giroctocogene fitelparvovec.
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