A phase II study of S-005151 in patients with chronic liver disease
- Conditions
- Chronic liver disease - Liver cirrhosis (alcoholic, non-alcoholic, HBV, or HCV)D008103
- Registration Number
- JPRN-jRCT2031200232
- Lead Sponsor
- Terai Shuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of adverse events during the S-005151 administration period and 14 days post-observation.
- Secondary Outcome Measures
Name Time Method Change ratio of liver stiffness mesured by MR elastography, Change ratio of liver stiffness mesured by ultrasound elastography,and Variation of Child-Pugh score.