Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
← catalyst calendarNCT05568719 · readout in 4,937 d
Sponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Other
Enrollment
173estimated
Sites
23
Countries
Australia, Canada, South Korea +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-28 | actual | When the study began enrolling |
| Primary completion | 2040-02-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2040-02-25 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hemophilia A
- Hemophilia B
Intervention
- Diagnostic test: Testing of hepatic AAV Vector integration
Primary outcomes
what the primary-completion date above is the date OFIncidence of thromboembolic events
measured Day 1 to 10 years
Incidence of factor inhibitor development
measured Day 1 to 10 years
Incidence of hepatic malignancy
measured Day 1 to 10 years
Incidence of liver abnormalities
measured Day 1 to 10 years
Factor activity level
measured Day 1 to 10 years
Publications
- PMID 22456059 — cited as background
- PMID 25059285 — cited as background
- PMID 12709033 — cited as background
- PMID 18929522 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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