Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Hemophilia B, sponsored by Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT03307980 still lists
NCT03307980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (78% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for Hemophilia B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03307980's enrollment target sits among peer trials
21 15th of 20 higher than 6 of 20 other Hemophilia B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
RECRUITING · Phase 3
-
BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
RECRUITING · Phase 1
-
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
RECRUITING · Phase 3
-
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
RECRUITING · Phase 3
-
Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)
RECRUITING · Phase 3
-
A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI