NCT03028740

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,778 (actual)
• Sponsor: Tobira Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Placebo	Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
DRUG	Cenicriviroc	Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.

Timeline

• Start date: 2017-04-05
• Primary completion: 2021-01-12
• Completion: 2021-03-09
• First posted: 2017-01-23
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

346 sites across 28 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Latvia, Mexico, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study