Clinical trial: BT200 in Hereditary Bleeding Disorders (NCT04677803)

Eligibility criteria:
Inclusion Criteria:To be eligible for this study, patients must meet all of the following
        inclusion criteria:

          1. Hereditary bleeding disorder:

               -  Congenital hemophilia A without inhibitors with a prophylactic treatment regime

               -  Heterozygous carriers of hemophilia A with subnormal FVIII levels

               -  VWD Type 1, "Vicenza" type

               -  VWD Type 2b

          2. Male or female, age ≥18-70 years old at Screening

          3. If female, must be post-menopausal or surgically sterilized

          4. Able to comprehend and to give informed consent

          5. Able to cooperate with the Investigator, to comply with the requirements of the study,
             and to complete the full sequence of protocol-related procedures -

        Exclusion Criteria: Patients meeting any of the following criteria will be excluded from
        the study:

          1. Clinically significant medical history or ongoing chronic illness that would
             jeopardize the safety of the patient or compromise the quality of the data derived
             from his/her participation in this study

          2. Medical History of spontaneous (not FVIII or FEIBA-associated) venous or arterial
             thromboembolic events

          3. History of significant drug allergy or anaphylactic reactions

          4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment
             of the Investigator for the patient to be able to comply fully with study procedures

          5. Use of medication during 2 weeks before the start of the study, which in the judgment
             of the Investigator may adversely affect the patient's welfare or the integrity of the
             study's results

          6. Concurrent treatment with other experimental drugs or participation in another
             clinical trial with any investigational drug within 30 days or 5 elimination
             half-lives (whichever is longer) prior to treatment start -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 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? Entailment