AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

  • STATUS
    Not Recruiting
  • End date
    Oct 28, 2028
  • participants needed
    2000
  • sponsor
    Tobira Therapeutics, Inc.
Updated on 11 April 2021
Investigator
Clinical Trials Registry Team
Primary Contact
Fundacion de Investigacion De Diego (1.8 mi away) Contact
+729 other location
fibrosis
hepatic fibrosis

Summary

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

Description

The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Subjects from Part 1 will continue into Part 2 and additional subjects will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.

Details
Condition Non-alcoholic Steatohepatitis, Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
Treatment Placebo, Cenicriviroc
Clinical Study IdentifierNCT03028740
SponsorTobira Therapeutics, Inc.
Last Modified on11 April 2021

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