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NCT04647227 · ClinicalTrials.gov record · last posted 2026-01-12

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

StatusRecruiting
PhasePhase 4
Started2021-06-28
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 29 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 29 times since 2020-11-23; most recent amendment 2026-01-09. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2021-06-28
Status change Active, Not Recruiting→Recruitingv3
2021-06-25
Status change Recruiting→Active, Not Recruitingv2
2021-04-19
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT04647227
Lead Sponsor American Thrombosis and Hemostasis Network
Collaborators: LFB USA, Inc.
Conditions Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Enrollment 55 participants
Start Date 2021-06-28
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-12