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Report for Clinical Trial NCT00470171

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis

This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis. The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group. The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.

NCT00470171 Serum Levels of ALAT Transaminases Serum Markers for Fibrosis and Hepatic Inflammation
MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease Inflammation
HPO:Hepatic steatosis

1 Interventions

Name: Ursodesoxycholic acid

Type: Drug


Primary Outcomes

Measure: A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 C282Y

- Alcohol consumption of >20 g/day for women and > 30 g/day for men - Hepatitis from other causes: chronic viral hepatitis B or C, elevated ferritin levels associated with C282Y homozygosity, primary biliary cirrhosis, primary sclerosing cholangitis, well documented auto-immune hepatitis (specific autoantibodies, hypergammaglobulinemia, consistent histologic changes), alpha1 antitrypsin deficiency, Wilson's disease, HIV infection. --- C282Y ---



HPO Nodes


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