Acquired hemophilia A
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) At least 18 years of age at time of informed consent. (2) Diagnosed with acquired hemophilia A. (3) FVIII activity = 0.6 BU/mL in the last test within 7 days before enrollment . (4) History of bleeds and/or bleeding symptoms related to acquired hemophilia A and have available records of bleeding episodes and treatment with coagulation factor products in the 24 weeks before enrollment.
Exclusion criteria
Exclusion criteria: (1) Have bleeding disorders other than acquired hemophilia A. (2) Have had treatment for thromboembolic disease within the last 12 months (except for prophylactic treatment). (3) History of clinically significant hypersensitivity associated with monoclonal antibody therapies or administration of globulin products. (4) At high risk for TMA, e.g., a previous medical or family history of TMA (thrombotic thrombocytopenic purpura [TTP], atypical hemolytic uremic syndrome, etc.), in the judgment of the investigator/subinvestigator. (5) Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the study. (6) Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Observation, Laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacodynamics Observation, Laboratory tests | — |
Countries
Japan
Outcome results
None listed