NCT00492700

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Association pour la Recherche sur les Maladies Hépatiques Virales · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Non Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	rosiglitazone

Timeline

• Start date: 2003-01-01
• First posted: 2007-06-27
• Last updated: 2007-06-27

Locations

1 site across 1 country: France