NCT01051219

Anti-Fibrotic Effects of Losartan In Nash Evaluation Study

A Randomised, Controlled Trial of Losartan as an Anti-fibrotic Agent in Non-alcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Losartan	50 milligrams to be taken orally, daily

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2010-01-18
• Last updated: 2015-10-07

Locations

10 sites across 1 country: United Kingdom