A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A
Public ClinicalTrials.gov record NCT03061201. 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.
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Official title
A PHASE 1/2, OPEN-LABEL, ADAPTIVE, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF SB-525 (PF-07055480) (RECOMBINANT AAV2/6 HUMAN FACTOR 8 GENE THERAPY) IN ADULT SUBJECTS WITH SEVERE HEMOPHILIA A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)
Study identification
- NCT ID
- NCT03061201
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 13 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 21, 2017 (Actual)
- Primary completion
- Jul 16, 2024 (Actual)
- Completion
- Jul 16, 2024 (Actual)
- Last update posted
- Sep 30, 2025
2017 – 2024
United States locations
- U.S. sites
- 22
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| City of Hope Medical Center | Duarte | California | 91010 | — |
| Midtown Ambulatory Care Center | Sacramento | California | 95817 | — |
| UC Davis Ambulatory Care Clinic | Sacramento | California | 95817 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UC Davis CTSC Clinical Research Center | Sacramento | California | 95817 | — |
| UC Davis Hemophilia Treatment Center | Sacramento | California | 95817 | — |
| UC Davis Investigational Drug Services Pharmacy | Sacramento | California | 95817 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| University of California, San Francisco - Investigational Drug Service (IDS) Pharmacy | San Francisco | California | 94143-0622 | — |
| University of California, San Francisco - Outpatient Hematology Clinic | San Francisco | California | 94143 | — |
| University of California, San Francisco -Moffitt Hospital | San Francisco | California | 94143 | — |
| University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| USF Health Morsani Center For Advanced Healthcare | Tampa | Florida | 33612 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Hemophilia Center of Western PA | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Montefiore Clinical and Translational Research Center | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC, Investigational Drug Service | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt University Medical Center Clinical Research Center | Nashville | Tennessee | 37212-8646 | — |
| Vanderbilt Hemostasis Treatment Clinic | Nashville | Tennessee | 37232 | — |
| Vanderbilt Hemostasis-Thrombosis Clinic | Nashville | Tennessee | 37232 | — |
| Washington Institute for Coagulation | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03061201, 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 Sep 30, 2025 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03061201 live on ClinicalTrials.gov.