Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B
Public ClinicalTrials.gov record NCT03307980. 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
A FACTOR IX (FIX) GENE TRANSFER, MULTI CENTER EVALUATION OF THE LONG TERM SAFETY AND EFFICACY STUDY OF PF 06838435 AND A DOSE ESCALATION SUBSTUDY IN INDIVIDUALS WITH HEMOPHILIA B
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Long-term safety and efficacy follow-up for participants with Hemophilia B who were previously treated in the C0371005 (formerly SPK-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. Participants in the substudy do not need to have participated in C0371005.
Study identification
- NCT ID
- NCT03307980
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- 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 22, 2017 (Actual)
- Primary completion
- Jul 23, 2026 (Actual)
- Completion
- Jul 23, 2026 (Actual)
- Last update posted
- Oct 5, 2026
2017 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UC Davis Ellison Ambulatory Care Clinic | Sacramento | California | 95817 | — |
| UC Davis Medical Center department of Radiology | Sacramento | California | 95817 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| UC Davis Midtown Cancer Center | Sacramento | California | 95817 | — |
| UC DavisHealth Main Hospital | Sacramento | California | 95817 | — |
| LA Center for Bleeding and Clotting Disorders - Metairie | Metairie | Louisiana | 70001 | — |
| Tulane Lakeside Hospital | Metairie | Louisiana | 70001 | — |
| LA Center for Bleeding and Clotting Disorders | New Orleans | Louisiana | 70112 | — |
| Tulane University Clinical Translational Unit | New Orleans | Louisiana | 70112 | — |
| Tulane University Hospitals and Clinic | New Orleans | Louisiana | 70112 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| Louisiana Center for Advanced Medicine | Slidell | Louisiana | 70461 | — |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | — |
| Weill Cornell Medicine - New York Presbyterian Hospital | New York | New York | 10065 | — |
| The Children's Hospital of Philadelphia | 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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03307980, 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 Oct 5, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03307980 live on ClinicalTrials.gov.