Nonalcoholic Steatohepatitis (NASH) is a disease that results when fat accumulates in the liver and eventually causes inflammation and scarring called fibrosis. Ocaliva (OCA) is an FDA approved drug for treating another type of liver disease. The purpose of this study is to test whether an experimental drug, OCA, is safe and effective in treating advanced scarring of the liver due to NASH.
Eligible patients will be randomly assigned to one of 2 drug doses or placebo. Neither you nor the researchers will know which drug you are taking. There are about 9 clinic visits in the first 12 months and typically 2 each year after that. At these visits researchers will ask you questions about your health, medications you are taking, and if you are having any problems with your health.
What we're hoping for
To find out if the study drug, OCA, is safe and effective for treating patients with NASH and fibrosis.
ClinicalTrials.gov Identifier: NCT02548351