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Clinical Trial Summary

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


Clinical Trial 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. Participants from Part 1 will continue into Part 2 and additional participants 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03028740
Study type Interventional
Source Tobira Therapeutics, Inc.
Contact
Status Terminated
Phase Phase 3
Start date April 5, 2017
Completion date March 9, 2021

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