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NCT03307980 · ClinicalTrials.gov registry record · Phase 2
Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B
A Phase 2 study of Hemophilia B, sponsored by Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 20
- Study locations
NCT03307980 is a Phase 2 study of Hemophilia B that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 21 participants, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT03307980, a Phase 2 study of Hemophilia B, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (78% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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.
NCT03307980 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Louisiana, California, Ontario.
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.
What interventions are being tested in trial NCT03307980?
The interventions under investigation include: PF-06838435 (formerly SPK-9001) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03307980?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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