Chronic liver disease - Liver cirrhosis (alcoholic, non-alcoholic, HBV, or HCV)
Conditions
Interventions
Subjects are divided into 2 cohorts with different dosage
the first 5 participant will be in cohort A, the next 5 in cohort B.
Cohort A: intravenous infusion of S-005151 on Day 1, 8, 15, and 22 (4 times in total).
Cohort B: intravenous infusion of S-005151 o
Sponsors
Terai Shuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [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.
Exclusion criteria
Exclusion criteria: [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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events during the S-005151 administration period and 14 days post-observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change ratio of liver stiffness mesured by MR elastography, Change ratio of liver stiffness mesured by ultrasound elastography,and Variation of Child-Pugh score. | — |
Contacts
Public ContactAtsunori Tsuchiya
Niigata University Medical and Dental Hospital
Outcome results
None listed