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A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

2014-08-27 03:37:46 | BioPortfolio

Summary

This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Description

Phase one : A double blind randomized placebo controlled trial of rosiglitazone

- 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.

- after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment

Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis

Phase II extension open label trial

All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Non Alcoholic Steatohepatitis

Intervention

rosiglitazone

Location

Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière
Paris
France
75013

Status

Completed

Source

Association pour la Recherche sur les Maladies Hépatiques Virales

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:37:46-0400

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Medical and Biotech [MESH] Definitions

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