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

Non Alcoholic Steatohepatitis Clinical Trial

— FLIRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492700
• Other study ID #: LIDO-Trials-01
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2007
• Last updated: June 26, 2007
• Start date: January 2003

Study information

• Verified date: June 2007
• Source: Association pour la Recherche sur les Maladies Hépatiques Virales
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
France	Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association pour la Recherche sur les Maladies Hépatiques Virales

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in steatosis
Secondary	improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis