Unique ID issued by UMIN | UMIN000001258 |
---|---|
Receipt number | R000001533 |
Scientific Title | Therapeutic fficacy of ezetimibe in patients with nonalcoholic steatohepatitis (NASH): a pilot study. |
Date of disclosure of the study information | 2008/07/23 |
Last modified on | 2010/09/28 18:00:20 |
Therapeutic fficacy of ezetimibe in patients with nonalcoholic steatohepatitis (NASH): a pilot study.
Efficacy of ezetimibe in NASH patients
Therapeutic fficacy of ezetimibe in patients with nonalcoholic steatohepatitis (NASH): a pilot study.
Efficacy of ezetimibe in NASH patients
Japan |
Nonalcoholic steatohepatitis (NASH)
Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Others
NO
To investigate the efficacy of ezetimibe for histologic improvement in subjects with nonalcoholic steatohepatitis.
Efficacy
Confirmatory
Pragmatic
Phase III
Before and after 6 months of ezetimibe (10mg daily) to nonalcoholic statohepatitis (NASH) patients, we assessed hepatic histologic features
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Historical
1
Treatment
Medicine |
administration of ezetimibe (10mg daily)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
a. The biopsy-proven nonalcoholic steatosis (NASH) patient will be evaluated in this study.
b. All patients gave their written informed consent to participation in the study.
a.The criteria for exclusion from participation in the study: history of hepatic disease, such as chronic hepatitis C or concurrent active hepatitis B (serum positive for hepatitis B surface antigen), autoimmune hepatitis, primary biliary cirrhosis (PBC), sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilsons disease, and current or past consumption of more than 20 g of alcohol daily.
b. None of the patients had any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, or elevated serum bilirubin level to more than twofold the upper limit of normal.
10
1st name | |
Middle name | |
Last name | Atsushi Nakajima |
Yokohama City University Hospital
Division of Gastroenterology
3-9 Fukuura, Kanazawaku, Yokohama, Japan
045-787-2640
1st name | |
Middle name | |
Last name | Masato Yoneda |
Yokohama City University Hospital
Division of Gastroenterology
3-9 Fukuura, Kanazawaku, Yokohama, Japan
045-787-2640
yoneda@med.yokohama-cu.ac.jp
Division of Gastroenterology, Yokohama City University Hospital
Grant from Ministry of Education, Science, Sports and Culture in Japan
Japan
NO
2008 | Year | 07 | Month | 23 | Day |
Published
Completed
2008 | Year | 07 | Month | 22 | Day |
2009 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2008 | Year | 07 | Month | 22 | Day |
2010 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001533
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |