AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
(AURORA Trial)
Recruiting in Palo Alto (17 mi)
+598 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Tobira Therapeutics, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
Male and female participants aged between 18-75 years
Ability to understand and sign a written informed consent form (ICF)
Histological evidence of NASH based on central reading of the Screening biopsy
See 2 more
Treatment Details
Interventions
- Cenicriviroc (CCR2/5 Inhibitor)
- Placebo (Drug)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cenicriviroc 150 mgExperimental Treatment1 Intervention
Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Cenicriviroc is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Cenicriviroc for:
- Non-alcoholic steatohepatitis (NASH)
- Liver fibrosis
🇪🇺 Approved in European Union as Cenicriviroc for:
- Non-alcoholic steatohepatitis (NASH)
- Liver fibrosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Digestive Health Specialists of the SoutheastDothan, AL
The Institute for Liver HealthChandler, AZ
Adobe Gastroenterology Research, LLCTucson, AZ
Del Sol Research Management, LLCTucson, AZ
More Trial Locations
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Who Is Running the Clinical Trial?
Tobira Therapeutics, Inc.Lead Sponsor