Clinical trial
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With…
NCT03861273 · Pfizer, Industry · Active, not recruiting
Key facts
| NCT number | NCT03861273 |
|---|---|
| Title | A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B |
| Official title | Phase 3, Open-label, Single-arm Study to Evaluate Efficacy and Safety of FIX Gene Transfer With PF-06838435 (rAAV-Spark100-hFIX-R338L) in Adult Male Participants With Moderately Severe to Severe Hemophilia B (FIX:C ≤2%) (BeneGene-2) |
| Acronym | BENEGENE-2 |
| Lead sponsor | Pfizer, Industry |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia B |
| Intervention type | Biological |
| Interventions | PF-06838435/ fidanacogene elaparvovec |
| Enrollment | 51 |
| Start date | Jul 29, 2019 |
| Primary completion | Nov 16, 2022 |
| Completion | Feb 25, 2031 |
| First posted | Mar 4, 2019 |
| Last update posted | Sep 30, 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: