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

• Sponsor: Association pour la Recherche sur les Maladies Hépatiques Virales (Other)
• Overall Status: Completed
• CT.gov ID: NCT00492700
• Collaborator: (none)
• Enrollment: 63
• Location: 1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Drug: rosiglitazone	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
• Study Start Date: Jan 1, 2003

Outcome Measures

Primary Outcome Measures

1. improvement in steatosis []

Secondary Outcome Measures

1. improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière	Paris		France	75013

Sponsors and Collaborators

• Association pour la Recherche sur les Maladies Hépatiques Virales

Investigators

• Principal Investigator: Vlad Ratziu, MD PhD, Hôpital Pitié Salpêtrière, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00492700
• Other Study ID Numbers: LIDO-Trials-01
• First Posted: Jun 27, 2007
• Last Update Posted: Jun 27, 2007
• Last Verified: Jun 1, 2007

• Keywords provided by , ,: steatosis,; fibrosis,; diabetes,; obesity
• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Rosiglitazone

Study Results

No Results Posted as of Jun 27, 2007