NCT04647227 SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
| NCT ID | NCT04647227 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | American Thrombosis and Hemostasis Network |
| Condition | Hemophilia A With Inhibitor |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-06-28 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 55 participants in total. It began in 2021-06-28 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Have a diagnosis of hemophilia A or B with inhibitors. 2. Be 12 years of age and older 3. 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 4. Have read, understood, and documented written informed consent/assent 5. Be able to provide medical evidence through prior medical history of previous inhibitor levels 6. Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage Exclusion Criteria: 1. Have a disorder of hemostasis in addition to Hemophilia A or B 2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients 3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins 4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA 5. Have had implantation of an investigational medical device within the prior 6 months 6. Have received an investigational drug within 30 days of the baseline visit 7. Have an elective surgical procedure planned during the duration of their participation in the study\* 8. 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) * Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary. Instead, the participant will receive standard of care treatment as determined by the attending physician. If the participant is not withdrawn from the study, the participant's participation in the study will be paused until the investigator feels it is safe for them to continue.
Contact & Investigator
Tammuella Chrisentery-Singleton, MD
PRINCIPAL INVESTIGATOR
American Thrombosis and Hemostasis Network
Frequently Asked Questions
Who can join the NCT04647227 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 100 Years, studying Hemophilia A With Inhibitor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04647227 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04647227 currently recruiting?
Yes, NCT04647227 is actively recruiting participants. Contact the research team at cfedor@athn.org for enrollment information.
Where is the NCT04647227 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Los Angeles, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT04647227 clinical trial?
NCT04647227 is sponsored by American Thrombosis and Hemostasis Network. The principal investigator is Tammuella Chrisentery-Singleton, MD at American Thrombosis and Hemostasis Network. The trial plans to enroll 55 participants.