Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
77actual
Sites
45
Countries
Australia, Brazil, Canada +13
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 | 2020-08-18 | actual | When the study began enrolling |
| Primary completion | 2024-06-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-25 | estimated | The whole study's end, after follow-up |
| First posted | 2020-04-30 | actual | When this record first appeared on the registry |
| Results posted | 2025-08-17 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hemophilia A
Intervention
- Biological: PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy — also filed as Gene Therapy
Primary outcome
what the primary-completion date above is the date OFTotal Annualized Bleeding Rate (ABR)
measured FVIII Prophylaxis arm: a minimum of 7.4 months, up to maximum of 32.3 months (Pre-infusion period); PF-07055480 arm: Week 12 through at least 15 months of follow-up, maximum follow up was of 44.4 months (Post-infusion period)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-11-15 · 1.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-05-09 · 738 KB · SAP_001.pdf
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