A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis (FLIRT)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis|
- improvement in steatosis
- improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
|Study Start Date:||January 2003|
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.
|Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière|
|Paris, France, 75013|
|Principal Investigator:||Vlad Ratziu, MD PhD||Hôpital Pitié Salpêtrière, APHP|