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

Primary Purpose

Non Alcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rosiglitazone
Sponsored by
Association pour la Recherche sur les Maladies Hépatiques Virales
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis focused on measuring steatosis,, fibrosis,, diabetes,, obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière

Outcomes

Primary Outcome Measures

improvement in steatosis

Secondary Outcome Measures

improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis

Full Information

First Posted
June 26, 2007
Last Updated
June 26, 2007
Sponsor
Association pour la Recherche sur les Maladies Hépatiques Virales
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1. Study Identification

Unique Protocol Identification Number
NCT00492700
Brief Title
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Acronym
FLIRT
Official Title
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Association pour la Recherche sur les Maladies Hépatiques Virales

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis
Keywords
steatosis,, fibrosis,, diabetes,, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Primary Outcome Measure Information:
Title
improvement in steatosis
Secondary Outcome Measure Information:
Title
improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlad Ratziu, MD PhD
Organizational Affiliation
Hôpital Pitié Salpêtrière, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19877169
Citation
Ratziu V, Charlotte F, Bernhardt C, Giral P, Halbron M, Lenaour G, Hartmann-Heurtier A, Bruckert E, Poynard T; LIDO Study Group. Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial. Hepatology. 2010 Feb;51(2):445-53. doi: 10.1002/hep.23270.
Results Reference
derived

Learn more about this trial

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

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