Combination treatment of LJN452 & CVC in patients with NASH
Research type
Research Study
Full title
A randomized, double-blind, multicenter study to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor(LJN452)and cenicriviroc(CVC)in adult patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis
IRAS ID
231956
Contact name
Claus-Peter Danzer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-004208-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 17 days
Research summary
Clinical research study to find out if the drugs tropifexor and cenicriviroc used as a combination therapy and separately are safe and have beneficial effects in adults who have non-alcoholic steatohepatitis(NASH)and liver fibrosis. NASH is a condition that results in liver inflammation and damage(liver fibrosis)due to a build up of fat in the liver. There are currently no drugs available to treat NASH.
The main purpose of the study is to investigate whether the combination treatment of tropifexor and cencriviroc is safe and tolerated in patients with NASH by monitoring adverse events, vital signs and laboratory values. This study
compares two doses of the combination therapy with tropifexor and cenicriciroc used alone.
Study participation will last for up to 62 weeks, including the screening,
treatment and follow-up periods.
The United Kingdom is looking for 6 patients from 3 sites.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0362
Date of REC Opinion
3 Aug 2018
REC opinion
Further Information Favourable Opinion