A phase II study of S-005151 in patients with chronic liver disease

Terai Shuji0 个研究点目标入组 10 人开始时间: 2020年12月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•[Preliminary registration: exam 1]
•1) 20 - 79 years old men and women on the date of consent.
•2) Patients capable of giving written informed consent.
•3) Patients with any of the following chronic liver disease.
•-Alcoholic steatohepatitis, abstaining from alcohol for more than 6 months.
•-Non-alcoholic steatohepatitis, on exercise and diet therapy for more than 6 months.
•-Chronic hepatitis B, with negative for HBV-DNA for at least 6 months after a treatment with nucleic acid analogues.
•-Past Chronic hepatitis C, attained a sustained virological response by antiviral therapy for more than 12 months.
•4) Child-Pugh score: 7 or less.
•5) Liver stiffness measurement by MR elastography: more than 4 kPa.
•[Registration: exam 2] (3 months after the preliminary registration)
•6) Uninterrupted the condition of 3)
•7) Child-Pugh Score fluctuation: within 1 point from exam 1.
•8) Liver stiffness remeasurement by MR elastography: more than 4 kPa.
•9) Undergone liver biopsy within the last 6 months.
•[Both exam 1 and 2]
•10) Women promised to practice reliable contracept specified in the protocol, or impossible to get pregnant.

•[Preliminary registration: exam 1]
•1) Expected to take any prohibited treatment during their study period.
•2) Prior regenerative medicine (cell therapy or gene therapy).
•3) Prior S-005151 administration.
•4) Investigational medicine within 90 days of enrollment.
•5) Pregnancy, lactation, or desire to have children in study period
•[Both exam 1 and 2]
•6) Autoimmune hepatitis, primary biliary cholangitis, or after liver transplantation.
•7) Hepatic encephalopathy.
•8) Repeated infections / fevers.
•9) Moderate to severe ascites.
•10) Gastroesophageal varices to treat, found within 6 months of enrollment.
•11) Interferon therapy within 6 months of enrollment.
•12) Anticagulants.
•13) Malignancy (except carcinoma in situ after curative resection, or relapse-free survival >5 years)
•14) Severe cardiovascular, renal, respiratory, or blood disease.
•15) Severe allergic disease or drug allergy.
•16) Inadequate physical condition, as diagnosed by their physician.

发起方

Terai Shuji