A single-arm, multicenter phase IIIB clinical trial to evaluate the safety and tolerability of prophylactic Emicizumab in Hemophilia A patients with inhibitors.

F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Signed Informed Consent Form
•2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the PRO questionnaires and bleed diaries through the use of an electronic device, as per the investigatorâ??s judgment
•3. Aged 12 years or older at the time of informed consent
•4. Body weight >=40 kg at the time of screening
•5. Diagnosis of congenital hemophilia A with persistent inhibitors against FVIII
•6. Adequate hematologic function
•7. Adequate hepatic function
•8. Adequate renal function

•1. Inherited or acquired bleeding disorder other than hemophilia A
•2. Ongoing (or plan to receive during the study) ITI therapy (prophylaxis regimens with FVIII and/or bypassing agents must be discontinued prior to enrollment).
•3. History of illicit drug or alcohol abuse within 12 months prior to screening, as per the investigatorâ??s judgment
•4. Other conditions (e.g., certain autoimmune diseases) that may increase the risk of bleeding or thrombosis
•5. History of clinically significant hypersensitivity reaction associated with monoclonal antibody therapies
•6. Known human immunodeficiency virus (HIV) infection
•7. Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study or that would, in the opinion of the investigator or Sponsor, preclude the patientâ??s safe participation in and completion of the study or interpretation of the study results

发起方

F HoffmannLa Roche Ltd