Study of TAK-672 in Participants With Acquired Hemophilia A
Study of TAK-672 in Participants With Acquired Hemophilia A
The main aims of the study are to learn if TAK-672 can control bleeds in participants with
 acquired hemophilia A and if the participants have side effects from TAK-672. Acquired
 hemophilia A is when people's immune system attacks specific proteins, known as clotting
 factors, in their bodies. This is different from hemophilia A, which is a condition people
 are born with.

 At the first visit, the study doctor will check who can take part. For those who can take
 part, participants will visit the clinic or hospital when they get their next bleed. They
 will receive TAK-672 slowly through a vein. This is called an infusion. They might need extra
 infusions of TAK-672 to control the bleed. After their bleed is controlled, participants will
 regularly visit the clinic for a check-up and to treat any further bleeds. This will happen
 until all participants have received their last dose of TAK-672 to control their 1st bleed.
 After this, all participants will visit the clinic 90 days later for a final check-up.
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.