Clinical Study for the Immunoadsorption Therapy of Dilated Cardiomyopathy using AMT-0902-1: Prospective, Multicenter, Randomized, Self- and Parallel Group- Comparative Study to Evaluate the Efficacy and Safety. - Randomized, Self- and Parallel Group- Comparative Trial using Immunoadsorption Plasma-apheresis of Dilated Cardiomyopathy(RESCUE DCM)

ASAHIKASEI KURAREY MEDICAL CO., LTD.0 个研究点目标入组 40 人开始时间: 2010年1月29日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1) Secondary DCM resulting from other diseases(e.g.hypertrophic or restrictive cardiomypathy) (2)Left ventricular noncompaction (3)Implanted with left ventricular assist device(LVAD) (4)Received Cardiac resynchronization therapy(CRT or CRT-D) in the past 6 months (5) Received Heart transplantation (6) Patients on an ACE inhibitor, which cannot be switched to an ARB (7)Weight <40kg (8)Platelet number <100,000/mm3 (9)Leukocyte number <3,000/mm3 (10)Anemia(hemoglobin <10 g/dL) (11)History of shock during extracorporeal circulation treatments (12) Impaired renal function (serum creatinine level >3 mg/dl) Impaired hepatic function (AST(GOT) or ALT(GPT) >2.5 times the upper limit of normal or >100 IU/L) (13) Being treated for a malignant tumor (14) Pregnant or potentially pregnant women or women who desire to become pregnant during the study period (15) Infected, or suspected to be infected, with HBV, HCV, or HIV (16) Patients who have difficulty understanding the informed consent document (17) Participation in any other clinical study within 26 weeks(182 days) before providing their informed consent (18) Previous treatments for DCM with AMT-0902-1 (19) Considered inappropriate for the clinical study by an investigator or subinvestigator

发起方

ASAHIKASEI KURAREY MEDICAL CO., LTD.