CENTAUR - CVC

• Research type

  Research Study

• Full title

  Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects with Liver Fibrosis

• IRAS ID

  164580

• Contact name

  Guru Aithal

• Contact email

  Guru.Aithal@nottingham.ac.uk

• Sponsor organisation

  Tobira Therapeutics, Inc.

• Eudract number

  2014-003164-21

• Clinicaltrials.gov Identifier

  NCT02217475

• Duration of Study in the UK

  2 years, 11 months, 18 days

• Research summary

  Nonalcoholic 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 characterized by the accumulation of fat in the liver. Around 2-5% of the UK population suffer from NASH (Nonalcoholic Steatohepatitis) which is a more advanced form of NAFLD where the buildup 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 a drug (‘CVC’) that helps block two receptors which play a role in inflammation and the development of fibrosis.

  This study is a double-blind, placebo-controlled, randomised study consisting of 3 treatment arms. Some participants will receive the active treatment (CVC) for 2 years, some participants will receive placebo in year 1 and CVC in year 2, and some will receive placebo throughout their participation in the study. A placebo looks like the study drug but does not contain any active ingredient.

  A: CVC once a day for 2 years
  B: Placebo once a day for the first year, CVC once a day for the second year
  C: Placebo once a day for 2 years

  Neither the participant nor the study doctor will be aware of which treatment was received.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/1209

• Date of REC Opinion

  25 Nov 2014

• REC opinion

  Further Information Favourable Opinion