jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

Dec. 04, 2020

June. 17, 2022

jRCT2031200232

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

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

Terai Shuji

Graduate School of Medical and Dental Sciences, Niigata University / Niigata University Medical and Dental Hospital

754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan.

+81-25-227-0730

terais@med.niigata-u.ac.jp

Tsuchiya Atsunori

Niigata University Medical and Dental Hospital

754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan. 951-8520

+81-25-227-0730

atsunori@med.niigata-u.ac.jp

Not Recruiting

Dec. 10, 2020

10

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

[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.

20age old over
80age old not

Both

Chronic liver disease - Liver cirrhosis (alcoholic, non-alcoholic, HBV, or HCV)

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).

D008103

D007262

Number of adverse events during the S-005151 administration period and 14 days post-observation.

Change ratio of liver stiffness mesured by MR elastography, Change ratio of liver stiffness mesured by ultrasound elastography,and Variation of Child-Pugh score.

SHIONOGI & CO., LTD.
Not applicable
Niigata University Medical and Dental Hospital IRB
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata

+81-25-227-0901

jimukyoku_ctrc@med.niigata-u.ac.jp
Approval

No

none

History of Changes

No Publication date
3 June. 17, 2022 (this page) Changes
2 Dec. 18, 2020 Detail Changes
1 Dec. 04, 2020 Detail