Clinical trial: Study of TAK-672 in Participants With Acquired Hemophilia A (NCT04580407)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female Japanese participants of >=18 years of age.

          2. Participants who (or their legally authorized representatives) have provided his/her
             written informed consent form prior to any study-related procedures and study product
             administration.

          3. Participants with a diagnosis of AHA based on clinical evaluation and supportive local
             laboratory testing as shown below:

               -  Presentation with spontaneous bleeding without anatomical cause and without prior
                  known bleeding disorder.

               -  Prolonged activated partial thromboplastin time (aPTT) without explanation.

               -  Abnormal aPTT cross mixing test consistent with FVIII inhibitors

               -  Confirmation of a low FVIII:C.

               -  Positive FVIII inhibitor (>=0.6 BU) as measured either in the local or central
                  laboratory

          4. Participants with a severe bleeding episode which the investigator finds necessary to
             treat and whose severe bleeding episode meets at least 1 of the following criteria:

               -  Bleeds that pose a threat to a vital organ that could threaten life (e.g.
                  intracranial bleed, or any site that could obstruct the airway).

               -  Bleeds that pose a threat to a vital organ where life is not threatened but the
                  organ function could be impaired (e.g., intraspinal bleed threatening the spinal
                  cord and/or nerve conduction; a continual bleed into the kidney or bladder that
                  could result in an obstructive uropathy, testicular bleed, bleed in and around
                  the eye).

               -  Bleeds requiring a blood transfusion to maintain the Hgb level at above-life or
                  organ threatening levels (e.g. post-surgical, gastro-intestinal,
                  retro-peritoneal, and thigh bleeds).

               -  Intramuscular bleeds where muscle viability and/or neurovascular integrity is
                  significantly compromised or at risk of being compromised.

               -  Intra-articular bleeds impacting a major joint associated with severe pain,
                  swelling and severe loss of joint mobility (reduced >70%) or where a bleed could
                  result in joint destruction (e.g. in and around the femoral head).

          5. Participants who are taking anti-thrombotics (including anti-platelet agents and
             anticoagulantswith confirmatory laboratory testing documenting specific FVIII
             inhibitor titer and with 3 half-lives of the agent have elapsed since the last dose.

          6. Participants with expected life expectancies of at least 90 days prior to the onset of
             the hemorrhagic episode.

          7. Participants of reproductive age who have agreed to use acceptable methods of
             contraception and if female, undergo pregnancy testing as part of the screening
             process.

          8. Participant who are able to willing and able to comply with the requirements of the
             protocol.

        Exclusion Criteria:

          1. Participants with an established reason for bleeding that is not correctable even with
             hemostatic therapy.

          2. Participants presenting a bleeding episode that is assessed likely to resolve on its
             own, even if left untreated.

          3. Participants with a known major sensitivity (anaphylactoid reactions) to therapeutic
             products of porcine or hamster origin; examples include therapeutics of porcine origin
             (e.g. previously marketed porcine FVIII, Hyate: C) and recombinant therapeutics
             prepared from hamster cells (e.g. Humira, Advate, and Enbrel).

          4. Participants with the use of hemophilia medication: prior to the administration of
             TAK-672 under one of the following conditions: (1) use of "recombinant activated
             factor VII (rFVI)Ia " within 3 hours prior to TAK-672 administration (2) use of "
             activated prothrombin complex concentrate (aPCC)" within 6 hours prior to TAK-672
             administration or (3) use of " plasma-derived FX/FVIIa complex concentrate
             (pd-FX/FVIIa) " within 8 hours prior to TAK-672 administration.

          5. Participants with an anticipated need for treatment or device during the study that
             may interfere with the evaluation of the safety or efficacy of TAK-672, or whose
             safety or efficacy may be affected by TAK-672.

          6. Participants who are currently pregnant or breastfeeding, or planning to become
             pregnant or father a child during the study

          7. Participants who have participated in another clinical study and has been exposed to
             an investigational product or device within 30 days prior to the study enrollment.

          8. Participants who are scheduled to participate in another non-observational
             (interventional) clinical study involving an investigational product or device during
             the course of the study.

          9. Participants who are unable to or unwilling to comply with the study design, protocol
             requirements, and/or the follow-up procedures.

         10. Participants whose majority of age are under legal protection.

         11. Participants who are an immediate family member, study site employee, or are in a
             dependent relationship with a study site employee who is involved in the conduct of
             this study (e.g. spouse, parent, child, sibling) or may consent under duress.

         12. Participants who are judged by the investigator as being ineligible for any other
             reason.
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.


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? 0