SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-100
SponsorAmerican Thrombosis and Hemostasis Network
About this trial
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.
Eligibility criteria
Qualifiers
Have a diagnosis of hemophilia A or B with inhibitors.
Be 12 years of age and older
Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and complying with the conditions of the protocol
Have read, understood, and documented written informed consent/assent
Disqualifiers
Have a disorder of hemostasis in addition to Hemophilia A or B
Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
Have a known allergy or hypersensitivity to rabbits or rabbit proteins
Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
Trial design
Treatments tested in this trial
- coagulation factor VIIa [recombinant]-jncw
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
American Thrombosis and Hemostasis Network
Lead sponsor
LFB USA, Inc.
Collaborator
Source ClinicalTrials.gov