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Hemophilia AGeneticsDiagnostics and screeningDiagnostic testPhase 3

What this study is

A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.

What's being tested

  • Testing of hepatic AAV Vector integration

    Intervention · DIAGNOSTIC TEST

    Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated

Study details

Official title
A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY
Sponsor
Pfizer
Conditions
Hemophilia A · Hemophilia B
Enrolling
173 people
Starts
2022-12-28
Est. completion
2040-02-25
Design
Open-label, non-randomized, single group, Phase 3
Record
View on ClinicalTrials.gov ↗