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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
coagulation factor VIIa [recombinant]-jncw
Druga 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.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Hemophilia A and B CasesOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants and percentage of Safety Events (AEs)
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.
Time frame
From time of consent through BE onset until 3 days after last dose of SEVENFACT®.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
American Thrombosis and Hemostasis Network
Lead sponsor
LFB USA, Inc.
Collaborator
Source ClinicalTrials.gov