Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B
NCT03307980 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL PF-06838435 (formerly SPK-9001)
Study Locations (20)
Louisiana
- LA Center for Bleeding and Clotting Disorders - Metairie — Metairie
- Tulane Lakeside Hospital — Metairie
- LA Center for Bleeding and Clotting Disorders — New Orleans
- Tulane University Clinical Translational Unit — New Orleans
- Tulane University Hospitals and Clinic — New Orleans
- Tulane University School of Medicine — New Orleans
- University Medical Center New Orleans — New Orleans
- Louisiana Center for Advanced Medicine — Slidell
California
- UC Davis Comprehensive Cancer Center — Sacramento
- UC Davis Ellison Ambulatory Care Clinic — Sacramento
- UC Davis Medical Center department of Radiology — Sacramento
- UC Davis Medical Center — Sacramento
- UC Davis Midtown Cancer Center — Sacramento
- UC DavisHealth Main Hospital — Sacramento
Ontario
- McMaster University Medical Centre - Hamilton Health Sciences — Hamilton
- McMaster University — Hamilton
Mississippi
- Mississippi Center for Advanced Medicine — Madison
New York
- Weill Cornell Medicine - New York Presbyterian Hospital — New York
Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia
New South Wales
- Royal Prince Alfred Hospital — Camperdown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-06-22 |
| Est. Completion | 2029-10-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03307980
The ClinicalTrials.gov registry entry for NCT03307980 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hemophilia B appearing as the primary indexed condition, and to 1 intervention — of which PF-06838435 (formerly SPK-9001) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03307980 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Louisiana, California, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03307980 about?
NCT03307980 is a clinical study titled "Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B". 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. Participa...
What is the current status of trial NCT03307980?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2017-06-22. Estimated completion is 2029-10-25.
What conditions does trial NCT03307980 study?
This clinical trial studies the following conditions: Hemophilia B. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03307980?
The interventions under investigation include: PF-06838435 (formerly SPK-9001) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03307980?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03307980 being conducted?
This trial has 20 study locations across California, Louisiana, Mississippi, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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