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SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

NCT04647227 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-01-12

No results posted yet for this 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.

Conditions

  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor

Interventions

DRUG

coagulation factor VIIa [recombinant]-jncw

a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

Sponsors & Collaborators

  • LFB USA, Inc.

    collaborator INDUSTRY

  • American Thrombosis and Hemostasis Network

    lead NETWORK

Principal Investigators

  • Tammuella Chrisentery-Singleton, MD · American Thrombosis and Hemostasis Network

  • Mark Reding, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647227 on ClinicalTrials.gov