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RECRUITING Phase 4

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

NCT04647227 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 55 participants
Start Date 2021-06-28
Est. Completion 2027-03-31
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04647227

The ClinicalTrials.gov registry entry for NCT04647227 describes a study currently listed as recruiting. It is categorized as Phase 4, 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 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Thrombosis and Hemostasis Network, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT04647227 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Michigan, California, Georgia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04647227?

The interventions under investigation include: coagulation factor VIIa [recombinant]-jncw (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04647227?

This trial is sponsored by American Thrombosis and Hemostasis Network, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial