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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association pour la Recherche sur les Maladies Hépatiques Virales
• Treatments: Rosiglitazone

Criteria

Inclusion Criteria:

• Histologically proven NASH with steatosis >= 20%

• Increased serum ALT

Exclusion Criteria:

• bland steatosis

• daily alcohol > 20/30 g (women/men)

• any other cause of liver disease

• secondary NASH including drug-induced steatohepatitis

• treatment with insulin or glitazones

• cardiac insufficiency

• Hb < 10 g/dl