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AURORA Study (Cenicriviroc)

Condition: Nonalcoholic steatohepatitis and liver fibrosis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Evidence of NASH
  • Evidence of Stage 2 or Stage 3 liver fibrosis

Key Exclusion Criteria

  • Inability to undergo a liver biopsy
  • Hepatitis B surface antigen positive
  • Hepatitis C antibody positive (with 2 exceptions)
Please see complete list of inclusion and exclusion criteria

Full Study Name

A Phase III, 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 (IRB no. 47704)

Summary

This study focuses on patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis. Steatohepatitis is a type of liver disease known as fatty liver, where the cells in the liver have abnormal accumulation of fat. Liver fibrosis develops as a consequence of inflammation and buildup of scar tissue in the liver. The purpose of the study is to determine whether an investigational drug called cenicriviroc (CVC) is safe and effective for the treatment of liver fibrosis in patients with NASH. Participants will be randomly assigned to receive either CVC along with information regarding diet and exercise, or a placebo drug along with information regarding diet and exercise.

Phase

Phase III

Principal Investigator

Mazen Noureddin, MD

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