CENTAUR Rollover study
Research type
Research Study
Full title
Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (NASH)
IRAS ID
222674
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
Tobira Therapeutics, Inc., a subsidiary of Allergan plc
Eudract number
2016-004754-15
Duration of Study in the UK
5 years, 10 months, 31 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) is a common liver disease linked with obesity-related disorders which occurs in people who drink little or no alcohol and is characterised by the accumulation of fat in the liver. Around 2-5% of the UK population suffer from Non-alcoholic Steatohepatitis (NASH) which is a more advanced form of NAFLD where the build-up of fat is complicated by damage to the liver cells and inflammation, potentially leading to fibrosis (thickening and scarred connective tissue). Current treatments to slow the progression of NASH include weight loss and exercise, stopping smoking, high blood pressure and cholesterol medication, and insulin for controlling type 2 diabetes. There is currently no specific medication for the treatment of NASH. Due to the growing epidemic of obesity and diabetes, the rising onset of NASH combined with a lack of approved therapeutic interventions represents an unmet medical need for therapies to treat NASH and slow down progression of the disease.
Tobira Therapeutics Inc. have developed an investigational medicine (Cenicriviroc (CVC)) that helps block two receptors which play a role in inflammation and the development of fibrosis. This open-label rollover study is being conducted to offer participants who successfully completed the 2-year CENTAUR study continued access to CVC. In addition, this study will evaluate the safety and tolerability of CVC with long-term treatment. Participants will attend regular study visits every 3 months for continued safety assessments. They will all take daily 150 mg CVC until it becomes commercially available or the sponsor decides to stop development of CVC.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/0592
Date of REC Opinion
5 Jun 2017
REC opinion
Further Information Favourable Opinion