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Fibrosis Effects of Losartan In Nash Evaluation Study

2014-08-27 03:16:34 | BioPortfolio

Summary

This is a randomised, 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 tisssue 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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Nonalcoholic Steatohepatitis

Intervention

Losartan

Location

Plymouth Hospitals NHS Trust
Plymouth
Devon
United Kingdom
PL6 8DH

Status

Not yet recruiting

Source

Newcastle-upon-Tyne Hospitals NHS Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

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PubMed Articles [335 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Cytoplasmic hyaline inclusions in HEPATOCYTES. They are associated with ALCOHOLIC STEATOHEPATITIS and non-alcoholic STEATOHEPATITIS, but are also present in benign and malignant hepatocellular neoplasms, and metabolic, toxic, and chronic cholestatic LIVER DISEASES.

An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.

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Hepatology
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...


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