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

This study has been completed.
Sponsor:
Information provided by:
Association pour la Recherche sur les Maladies Hépatiques Virales
ClinicalTrials.gov Identifier:
NCT00492700
First received: June 26, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Association pour la Recherche sur les Maladies Hépatiques Virales

Additional 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
Study First Received: June 26, 2007
Last Updated: June 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014