Dec. 04, 2020 |
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June. 17, 2022 |
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jRCT2031200232 |
A phase II study of S-005151 in patients with chronic liver disease |
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A phase II study of S-005151 in patients with chronic liver disease |
Terai Shuji |
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Graduate School of Medical and Dental Sciences, Niigata University / Niigata University Medical and Dental Hospital |
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754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan. |
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+81-25-227-0730 |
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terais@med.niigata-u.ac.jp |
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Tsuchiya Atsunori |
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Niigata University Medical and Dental Hospital |
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754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan. 951-8520 |
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+81-25-227-0730 |
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atsunori@med.niigata-u.ac.jp |
Not Recruiting |
Dec. 10, 2020 |
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10 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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[Preliminary registration: exam 1] |
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[Preliminary registration: exam 1] |
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20age old over | ||
80age old not | ||
Both |
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Chronic liver disease - Liver cirrhosis (alcoholic, non-alcoholic, HBV, or HCV) |
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Subjects are divided into 2 cohorts with different dosage; the first 5 participant will be in cohort A, the next 5 in cohort B. |
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D008103 |
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D007262 |
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Number of adverse events during the S-005151 administration period and 14 days post-observation. |
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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 |
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jimukyoku_ctrc@med.niigata-u.ac.jp | |
Approval | |
No |
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none |