Clareo Health | Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–64
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Males who have been followed on routine Factor VIII prophylaxis therapy during the lead-in study (C0371004) and have \> = 150 documented exposure days to a Factor VIII protein product
Moderately severe to severe hemophilia A (Factor VIII activity \< =1%)
Suspension of FVIII prophylaxis therapy post study drug infusion
You may not be if
Anti-AAV6 neutralizing antibodies
History of inhibitor to Factor VIII
Laboratory values at screening visit that are abnormal or outside acceptable study limits
Conditions associated with increased thromboembolic risk such as inherited or acquired thrombophilia, or a history of thrombotic events
Planned surgical procedure requiring Factor VIII surgical prophylactic factor treatment 12 months from screening visit
Active hepatitis B or C
Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with Cluster of Differentiation 4 positive (CD4+) cell count ≤200 mm3 and/or viral load \>20 copies/mL
