Clinical trial: SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (NCT04647227)

Eligibility criteria:
Inclusion Criteria:

          1. Have a diagnosis of hemophilia A or B with inhibitors.

          2. Be 12 - 65 years of age inclusive

          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                  withdrawn from the study unless the investigator deems it necessary.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 If the participant is not withdrawn from the study, the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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction