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 range
12 Years – 100 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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
. 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)