A MULTICENTER, OPEN-LABEL, NON-RANDOMIZED, PHASE III STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 14 人开始时间: 2020年2月7日最近更新: 2024年4月1日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Chugai Pharmaceutical Co., Ltd.
入组人数: 14

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•(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.

排除标准

•(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.

研究者

发起方

Chugai Pharmaceutical Co., Ltd.

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