SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
This study is looking at the safety of SEVENFACT® (coagulation factor VIIa [recombinant]-jncw) for treating bleeding events in people with hemophilia A or B who have inhibitors. Inhibitors are antibodies that make standard hemophilia treatments less effective. You might be eligible if you are 12 years or older and have hemophilia A or B with inhibitors. This includes those already on preventative treatment (like emicizumab) who might have a breakthrough bleed, or those not on preventative treatment who need to control a bleed. The main goal is to see how safe SEVENFACT® is when used for these bleeding episodes. The study is currently enrolling participants.
- Study design
- This is a Phase IV, multi-center, open-label safety study. It aims to enroll between 28 and 55 participants.
- What's involved
- You will be followed from enrollment until the end of your participation, for up to approximately 4 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed from the time of consent through the start of a bleeding event until 3 days after your last dose of SEVENFACT®.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
At a glance
Conditions
Where it's being run
21 sites across 16 statesStudy leadership
- Tammuella Chrisentery-Singleton, MD · PRINCIPAL_INVESTIGATOR · American Thrombosis and Hemostasis Network
- Mark Reding, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Exclusion
What this trial measures
- Number of participants and percentage of Safety Events (AEs)From time of consent through BE onset until 3 days after last dose of SEVENFACT®.
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.