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 groupLocations
21Arizona
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital85016, Phoenix United States
Arkansas
Arkansas Center for Bleeding Disorders72202, Little Rock United States
California
Orthopaedic Institute for Children90007, Los Angeles United States
University of California at Davis UC Davis Hemostasis and Thrombosis Center95817, Sacramento United States
Sponsors and collaborators
American Thrombosis and Hemostasis Network
Lead sponsor
LFB USA, Inc.
Collaborator
Source ClinicalTrials.gov