PHASE III STUDY OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A (AGEHA)
- Conditions
- Acquired hemophilia A
- Registration Number
- JPRN-jRCT2080225056
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
These results in this study suggest that emicizumab prophylaxis with the modified dosing regimen and completion criteria for AHA has a favorable benefit-risk profile in patients with AHA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 14
(1) At least 18 years of age at time of informed consent.
(2) Diagnosed with acquired hemophilia A.
(3) FVIII activity < 50 IU/dL and FVIII inhibitors >= 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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Observation, Laboratory tests
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>pharmacodynamics<br>Observation, Laboratory tests