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
Public ClinicalTrials.gov record NCT03861273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Study identification
- NCT ID
- NCT03861273
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Pfizer
- Industry
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- PF-06838435/ fidanacogene elaparvovec Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- Male
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 28, 2019
- Primary completion
- Nov 15, 2022
- Completion
- Feb 24, 2031
- Last update posted
- Apr 19, 2026
2019 – 2031
United States locations
- U.S. sites
- 16
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF IDS Pharmacy | San Francisco | California | 94143 | — |
| University of California, San Francisco - Clinical Research Center | San Francisco | California | 94143 | — |
| University of California, San Francisco - Outpatient Hematology Clinic | San Francisco | California | 94143 | — |
| The Regents of the University of California, San Francisco campus | San Francisco | California | 94158 | — |
| Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Regents of the University of Colorado University of Colorado Denver, Office of Grants and Contracts | Aurora | Colorado | 80045 | — |
| Indiana Hemophilia & Thrombosis Center, Inc. | Indianapolis | Indiana | 46260 | — |
| Indiana Hemophilia and Thrombosis Center, Inc | Indianapolis | Indiana | 46260 | — |
| Innovative Hematology, Inc. | Indianapolis | Indiana | 46260 | — |
| St. Vincent Hospital & Health Care Center, Inc. | Indianapolis | Indiana | 46260 | — |
| Madison Radiological Group | Madison | Mississippi | 39110 | — |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | — |
| Center for Human Phenomic Science | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Drug Service | Philadelphia | Pennsylvania | 19104 | — |
| Penn Blood Disorder Center | Philadelphia | Pennsylvania | 19104 | — |
| The Trustees of the University of Pennsylvania, Office of Clinical Research- Legal | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03861273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 19, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03861273 live on ClinicalTrials.gov.