Unique ID issued by UMIN | UMIN000039146 |
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Receipt number | R000044646 |
Scientific Title | Effect of elobixibat on bile acid metabolism in patients with primary biliary cholangitis or fatty liver |
Date of disclosure of the study information | 2020/01/16 |
Last modified on | 2020/01/29 13:39:32 |
Effect of elobixibat on bile acid metabolism in patients with primary biliary cholangitis or fatty liver
Effect of elobixibat on bile acid metabolism in patients with primary biliary cholangitis or fatty liver
Effect of elobixibat on bile acid metabolism in patients with primary biliary cholangitis or fatty liver
Effect of elobixibat on bile acid metabolism in patients with primary biliary cholangitis or fatty liver
Japan |
primary biliary cholangitis or fatty liver
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the effect of elobixibat on bile acid metabolism in patients with primary biliary cholangitis or fatty liver
Safety,Efficacy
serum ALP levels in 12 months in PBC patients
serum ALT levels in 12 months in FL patients
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients with PBC or NAFLD who have constipation
1. patients who are suspected to have ileus.
2. patients with severe CKD.
3, patients with severe liver dysfunction (C-P: B or C).
4. Patients with uncontrolled malignancy.
40
1st name | Tatehiro |
Middle name | |
Last name | Kagawa |
Tokai University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
259-1193
143 Shimokasuya, Isehara
81-463-93-1121
kagawa@tokai.ac.jp
1st name | Tatehiro |
Middle name | |
Last name | Kagawa |
Tokai University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine,
259-1193
143 Shimokasuya, Isehara
81-463-93-1121
kagawa@tokai.ac.jp
Tokai University School of Medicine
Tokai University School of Medicine
Self funding
Institutional Review Board for Clinical Research, Tokai University
143 Shimokasuya, Isehara
81-463-93-1121
tokai-rinsho@ml.tokai-u.jp
NO
2020 | Year | 01 | Month | 16 | Day |
Unpublished
Open public recruiting
2018 | Year | 08 | Month | 20 | Day |
2019 | Year | 08 | Month | 14 | Day |
2020 | Year | 01 | Month | 16 | Day |
2021 | Year | 03 | Month | 31 | Day |
1. Change in body weight, BMI, body fat percentage
2. Change in intestinal flora
3. Change in liver stiffness and hepatic fat
2020 | Year | 01 | Month | 14 | Day |
2020 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044646
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