Therapeutic fficacy of ezetimibe in patients with nonalcoholic steatohepatitis (NASH): a pilot study.

UMIN ID: UMIN000001258

Registered date:23/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Nonalcoholic steatohepatitis (NASH)
• Date of first enrollment: 2009/09/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): administration of ezetimibe (10mg daily)

Outcome(s)

• Primary Outcome: Before and after 6 months of ezetimibe (10mg daily) to nonalcoholic statohepatitis (NASH) patients, we assessed hepatic histologic features

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Division of Gastroenterology, Yokohama City University Hospital
• Source(s) of Monetary Support: Grant from Ministry of Education, Science, Sports and Culture in Japan