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AURORA: Phase 3 Cenicriviroc in Adults with NASH - 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.

What is the Condition Being Studied?

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

Age Group
Adults

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

Study Details

Full Title
AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis
Principal Investigator
Protocol Number
IRB:PRO00081512
NCT:NCT03028740
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698