Clinical trial: Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients (NCT04396639)

Eligibility criteria:
Inclusion Criteria:

          1. Male subjects ≥12 years to ≤65 years with a diagnosis of congenital moderate or severe
             hemophilia A (FVIII:C ≤5%).

          2. Documented history of at least 50 exposure days (EDs) to FVIII-containing products.

          3. Evidence of a personally signed and dated informed consent document indicating that
             the subject (or a legally acceptable representative, parent(s)/legal guardian) has
             been informed of all pertinent aspects of the study. For minors under the age of legal
             consent in India, assent of the participating child needs to be documented for the age
             range 12 to 18 in addition to the parental informed consent.

        Exclusion Criteria:

          1. Prior history of inhibitor to FVIII or positive inhibitor testing (≥0.6 BU/mL) during
             Screening. Clinical signs or symptoms of decreased response to FVIII.

          2. Known hypersensitivity to the active substance or any of the excipients.

          3. Known allergic reaction to hamster proteins.

          4. Presence of any bleeding disorder in addition to hemophilia A.

          5. Participation in other studies involving investigational drug(s) (Phases 1-4) within
             30 days before the current study begins and/or during study participation.

          6. Planned surgery within 6 months from the start of the study.

          7. Unsuitable to participate in study for any other reason as assessed by the
             investigator; including any disorder, except for conditions associated with hemophilia
             A, which in the investigator's opinion might jeopardize subject's safety or compliance
             with the protocol.

          8. Subjects (or a legally acceptable representative) is not able to understand study
             documents and study procedure.

          9. Immunocompromised subjects due to human immunodeficiency virus (HIV) infection
             (defined as viral load above or equal to 100,000 copies/mL; and for HIV+ subjects:
             cluster of differentiation 4 positive (CD4+) lymphocyte count below or equal to
             200/μL). HIV status and CD4+ lymphocyte count results may be obtained at screening or
             from available medical records; results must be not older than 6 months prior to
             screening.

         10. Subjects who are investigational site staff members directly involved in the conduct
             of the study and their family members, site staff members otherwise supervised by the
             Investigator, subjects who have been previously enrolled into the study, or subjects
             who are Pfizer employees directly involved in the conduct of the study.

         11. Planned use of any non-study medication for treatment of hemophilia (eg, other factor
             replacement agents, bypassing agents, or non-factor treatments [such as anti-tissue
             factor pathway inhibitors]).

             -
Male
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