NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-205151

Registered date:07/02/2020

PHASE III STUDY OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A (AGEHA)

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studiedAcquired hemophilia A
Date of first enrollment15/6/2020
Target sample size11
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : emicizumab (ACE910, RO5534262) INN of the intervention : emicizumab Dosage And administration of the intervention : Emicizumab will be administered subcutaneously once weekly. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomesafety Observation, Laboratory tests
Secondary Outcomeefficacy, pharmacokinetics, pharmacodynamics Observation, Laboratory tests

Key inclusion & exclusion criteria

Age minimum18
Age maximum
GenderBOTH
Include criteria(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.
Exclude 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.

Related Information

Contact

public contact
Name Chugai Pharmaceutical Co., Ltd. Clinical trials information
Address
Telephone
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation
scientific contact
Name Chugai Pharmaceutical Co., Ltd. Clinical trials information
Address
Telephone
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation