Nonalcoholic Steatohepatitis (NASH) results when fat accumulates in the liver and causes inflammation and scarring called fibrosis. Fibrosis can lead to cirrhosis which impairs liver function. Ocaliva (OCA) is an FDA approved drug for treating another type of liver disease. This study will test if Ocaliva (OCA) is safe and effective in treating cirrhosis of the liver caused by advanced NASH.
Eligible patients will be randomly assigned to take study drug or placebo. Neither you nor the researchers will know which you are taking. There are approximately 9 study visits during the first year and 8 study visits the second year. 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 Compensated Cirrhosis due to NASH.
ClinicalTrials.gov Identifier: NCT03439254