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NCT04647227 · ClinicalTrials.gov registry record · Phase 4
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
A Phase 4 study of Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, sponsored by American Thrombosis and Hemostasis Network.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
- 20
- Study locations
NCT04647227: Recruiting Phase 4 study of Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, sponsored by American Thrombosis and Hemostasis Network.
NCT04647227 is a Phase 4 study of Hemophilia A With Inhibitor and Hemophilia B With Inhibitor that is actively recruiting participants, run by American Thrombosis and Hemostasis Network. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04647227, a Phase 4 study of Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, is actively recruiting participants, sponsored by American Thrombosis and Hemostasis Network.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.
Primary Outcome
Adverse Events and SAEs defined by the European Haemophilia Safety Surveillance System 2018 (EUHASS) and Serious Adverse Events (SAEs) as defined by the US Food and Drug Association.
Conditions Studied
Interventions
- DRUG coagulation factor VIIa [recombinant]-jncw
Study Locations (20)
Michigan
- Children's Hospital of Michigan - Detroit
- Henry Ford Health System - Detroit
- MSU Center for Bleeding and Clotting Disorders - Lansing
California
- Orthopaedic Institute for Children - Los Angeles
- University of California at Davis UC Davis Hemostasis and Thrombosis Center - Sacramento
Georgia
- Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division - Atlanta
- Willett Children's Hospital at Memorial University Medical Center - Savannah
Minnesota
- Center for Bleeding and Clotting Disorders, University of Minnesota - Minneapolis
- Mayo Comprehensive Hemophilia Center - Rochester
Arizona
- Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Center for Bleeding Disorders - Little Rock
District of Columbia
- Children's National Hemophilia Center - Washington D.C.
Florida
- Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 4 |
What NCT04647227 shows while recruiting
NCT04647227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Hemophilia A With Inhibitor appearing as the primary indexed condition, and to 1 intervention - of which coagulation factor VIIa [recombinant]-jncw is the first listed.
NCT04647227 names 20 study sites across 15 states, led by Michigan, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04647227 about?
NCT04647227 is a clinical study titled "SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors". Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on pr...
What is the current status of trial NCT04647227?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2021-06-28. Estimated completion is 2027-03-31.
What conditions does trial NCT04647227 study?
This clinical trial studies the following conditions: Hemophilia A With Inhibitor, Hemophilia B With Inhibitor.
What interventions are being tested in trial NCT04647227?
The interventions under investigation include: coagulation factor VIIa [recombinant]-jncw (DRUG).
Who is sponsoring clinical trial NCT04647227?
This trial is sponsored by American Thrombosis and Hemostasis Network, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04647227 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A With Inhibitor
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 NCT04647227's enrollment target sits among peer trials
55 1218th of 2000 higher than 779 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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