SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (NCT04647227) | Clinical Trial Compass
RecruitingPhase 4
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
United States55 participantsStarted 2021-06-28
Plain-language summary
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.
Who can participate
Age range12 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Be able to provide medical evidence through prior medical history of previous inhibitor levels
✓. Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage
Exclusion criteria
✕. 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
✕. Have had implantation of an investigational medical device within the prior 6 months
✕. Have received an investigational drug within 30 days of the baseline visit
What they're measuring
1
Number of participants and percentage of Safety Events (AEs)
Timeframe: From time of consent through BE onset until 3 days after last dose of SEVENFACT®.
. Have an elective surgical procedure planned during the duration of their participation in the study\*
✕. Have any life-threatening disease, or other disease or condition which, in the investigator's judgment, could pose a potential hazard to the patient or interfere with study participation or study outcome (e.g., a history of non responsiveness to bypassing products or thromboembolic disease)