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

Association pour la Recherche sur les Maladies Hépatiques Virales

Status and phase

Completed

Phase 2

Conditions

Non Alcoholic Steatohepatitis

Treatments

Drug: rosiglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT00492700

LIDO-Trials-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

63 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria