Anti-Fibrotic Effects of Losartan In Nash Evaluation Study
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized, controlled 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. NASH 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, which may lead to cirrhosis, in which the liver is permanently
damaged and scarred and no longer able to function properly.
Primary hypothesis:
That losartan is superior to placebo in reversing, slowing down or halting fibrosis in
patients with non-alcoholic fatty liver disease, after 24 months of treatment.
Secondary hypothesis:
1. That the safety profile of the angiotensin receptor blocker (losartan) in this patient
population is acceptable
2. That losartan can prevent clinical deterioration in non-alcoholic fatty liver disease
3. That serum, radiological and histological markers of fibrosis correlate in these
patients over a 24 month period