AURORA
Research type
Research Study
Full title
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
IRAS ID
222303
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
Tobira Therapeutics, a subsidiary of Allergan plc
Eudract number
2016-004566-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 10 months, 0 days
Research summary
This is a Phase 3, multicenter, randomised, double-blind, placebo controlled study of Cenicriviroc Mesylate (CVC) for the treatment of Stage 2 to 3 liver fibrosis in adult participants with Nonalcoholic Steatohepatitis (NASH). The study will be conducted in 2 parts: Part 1 (surrogate endpoint) and Part 2 (clinical outcomes).
Nonalcoholic fatty liver disease (NAFLD) is a common, often “silent” liver disease associated with obesity related disorders (such as type-2 diabetes) occurring in people who consume little or no alcohol and is characterised by the accumulation of fat in the liver with no other apparent causes.
NASH is usually described as a severe form of NAFLD, with or without fibrosis. Liver fibrosis is the condition developed as a consequence of inflammation and build-up of scar tissue in the liver.
The rising prevalence of obesity-related disorders has contributed to a rapid increase in the prevalence of NASH. Approximately 10% to 20% of participants with NAFLD will progress to NASH. Due to the growing epidemic of obesity and diabetes worldwide, NASH is projected to become the most common cause of advanced liver disease and the most common indication for liver transplantation. The burden of NASH, combined with a lack of any approved therapeutic interventions, represents an unmet medical need.
This study is being conducted to identify:
-How effective CVC is when compared to a placebo for the treatment of liver fibrosis in participants with NASH.
-How safe CVC is when compared to a placebo.In Part 1, approximately 1000 (50) participants will be randomised 2:1 to receive CVC or placebo. In Part 2 will include approximately 2000 (100) participants, of which up to1000 participants will have been randomised in Part 1 and will focus on assessing the effect of CVC on clinical outcomes.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0247
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion