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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492700
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Association pour la Recherche sur les Maladies Hépatiques Virales
  Purpose
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 Intervention Phase
Non Alcoholic Steatohepatitis Drug: rosiglitazone Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Association pour la Recherche sur les Maladies Hépatiques Virales:

Primary Outcome Measures:
  • improvement in steatosis

Secondary Outcome Measures:
  • improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis

Enrollment: 63
Study Start Date: January 2003
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492700


Locations
France
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00492700     History of Changes
Other Study ID Numbers: LIDO-Trials-01
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
Last Verified: June 2007

Keywords provided by Association pour la Recherche sur les Maladies Hépatiques Virales:
steatosis,
fibrosis,
diabetes,
obesity

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs