AURORA: Phase 3 Cenicriviroc Study in Adults with NASH (Liver Fibrosis) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to see how well a single daily dose of the study drug, Cenicriviroc (CVC) works at reducing inflammation and fibrosis in the liver.
Nonalcoholic Fatty Liver Disease (NASH)
Who Can Participate in the Study?
Adults age 18-75 years of age who:
- Have of NASH, as shown by a liver biopsy
- Are willing and available to come to study visits at Duke over the next several years
What is Involved?
The study will be done in two parts: Part 1 will last for 12 months and Part 2 will last for up to 96 months (8 years).
If you agree to join the study, you will:
- Have a screening visit to see if you are eligible to join the study
- Be randomly assigned (like drawing numbers from a hat) to either one of two groups
-- One group will get a study drug called CVC (you will have a 2 out of 3 chance of being in this group)
-- One group will get a placebo (a sugar pill) (you will have a 1 out of 3 chance of being in this group)
(Neither you nor your study doctor or the study team will know which group you are in or what you are getting)
- Have study visits about every 3 months
- You may have up to 3 liver biopsies during the study