Long-Term Safety and Effectiveness Study of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Adults with Hemophilia A or B

What this Trial Is About

Researchers are studying the long-term safety and effectiveness of two gene therapies, giroctocogene fitelparvovec and fidanacogene elaparvovec, in adult male patients with Hemophilia A or Hemophilia B. These patients have previously received these treatments in Pfizer-sponsored clinical trials. The study aims to collect data over a period of up to 10 years to monitor important health outcomes related to these therapies. Participants have already been treated with one of the gene therapies in earlier studies and will not receive any new investigational treatment in this study. The study involves ongoing observation and data collection based on standard medical care, without additional treatment interventions. Specific monitoring includes laboratory testing and possibly liver biopsies when clinically necessary to evaluate the presence of the viral vector used in the gene therapies. During the study, participants will have regular visits and assessments to track health outcomes such as thromboembolic events, development of factor inhibitors, liver abnormalities, and factor activity levels over the 10-year period. Researchers will also monitor bleeding rates, immune system responses, serious adverse events, and quality of life measures. The study is designed to provide long-term information on the safety and effectiveness of the prior gene therapy treatments, with participant involvement based on routine clinical care schedules.

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively