Fibrosis Effects of Losartan in Nash Evaluation Study- FELINE - V1.0
Research type
Research Study
Full title
A randomised controlled trial of Losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis.
IRAS ID
37194
Contact name
Christopher Paul Day
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2009-015166-62
ISRCTN Number
57849521
Clinicaltrials.gov Identifier
Research summary
This is a randomised, double-blind, placebo-controlled, parallel-group trial to determine whether Losartan is effective at slowing down, halting or reversing liver fibrosis in patients with non-alcoholic steatohepatitis (NASH). Liver fibrosis is the accumulation of tough, fibrous scar tissue in the liver which occurs in patients with NASH. This resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. NASH may be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred, and no longer able to function properly. In the study, patients aged 18 or over will be either given Losartan or a dummy pill. Losartan is a pill used widely in patients with high blood pressure, a condition common in NASH. It is also used for the treatment of renal disease in patients with hypertension, in patients with diabetes and in chronic heart failure. Throughout the study, patients will undergo assessment of their condition by means of blood samples, liver biopsy and scanning of the liver over a two-year period. Some of these procedures are carried out in the routine clinical care of these patients. 214 patients will be recruited in total within seven sites in the United Kingdom.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
10/H0904/8
Date of REC Opinion
23 Mar 2010
REC opinion
Further Information Favourable Opinion