Long-Term Safety of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec for Hemophilia A or B
This study is looking at the long-term safety and effectiveness of two gene therapies, giroctocogene fitelparvovec and fidanacogene elaparvovec, for men with hemophilia A or B. These therapies were previously given to participants in other Pfizer studies. Researchers want to see if these treatments cause any serious side effects like blood clots (thromboembolic events), the body developing resistance to the treatment (factor inhibitor development), or liver cancer (hepatic malignancy) over a 10-year period. You can join this study only if you have already received one of these treatments in a specific Pfizer-sponsored clinical trial. The study plans to enroll 173 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants receive a specific treatment. It is designed to follow 173 men who previously received giroctocogene fitelparvovec or fidanacogene elaparvovec.
- What's involved
- Data collection and participant visits will be based on standard of care. This may include evaluation of AAV vector integration if a liver sample is obtained.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 10 years to monitor for specific safety events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
At a glance
Conditions
Where it's being run
23 sites across 13 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of thromboembolic eventsDay 1 to 10 years
- Incidence of factor inhibitor developmentDay 1 to 10 years
FIX inhibitor development was defined as an inhibitor titer \>= 0.6 Bethesda units per milliliter (BU/mL).
- Incidence of hepatic malignancyDay 1 to 10 years
- Incidence of liver abnormalitiesDay 1 to 10 years
- Factor activity levelDay 1 to 10 years
Factor activity level will be reported. Factor levels may be measured using different assay methods including a one-stage assay or by chromogenic substrate assay and a second one-stage assay.