Clinical trial
Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene…
NCT04370054 · Pfizer, Industry · Active, not recruiting
Key facts
| NCT number | NCT04370054 |
|---|---|
| Title | Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults |
| Official title | Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants With Moderately Severe to Severe Hemophilia A(FVIII:C≤1%) |
| Acronym | AFFINE |
| Lead sponsor | Pfizer, Industry |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia A |
| Intervention type | Biological |
| Interventions | PF-07055480 (giroctocogene fitelparovec): Recombinant AAV2/6 Human Factor VIII Gene Therapy |
| Enrollment | 77 |
| Start date | Aug 18, 2020 |
| Primary completion | Jun 17, 2024 |
| Completion | Oct 25, 2028 |
| First posted | Apr 30, 2020 |
| Last update posted | Aug 17, 2025 |
| Countries | Australia, Brazil, Canada, France, Germany, Greece, Italy, Japan, Saudi Arabia, South Korea, Spain, Sweden and 4 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: