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

JRCT ID: jRCT2031200232

Registered date:04/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic liver disease - Liver cirrhosis (alcoholic, non-alcoholic, HBV, or HCV)
• Date of first enrollment: 10/12/2020
• Target sample size: 10
• Study type: Interventional

Intervention(s)

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 on Day 1, 2, 3, 4, 8, 15, and 22 (7 times in total).

Outcome(s)

• Primary Outcome: Number of adverse events during the S-005151 administration period and 14 days post-observation.
• Secondary Outcome: Change ratio of liver stiffness mesured by MR elastography, Change ratio of liver stiffness mesured by ultrasound elastography,and Variation of Child-Pugh score.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Terai Shuji
• Source(s) of Monetary Support: SHIONOGI &amp; CO., LTD.