NCT00492700

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
Last Updated

June 27, 2007

Status Verified

June 1, 2007

First QC Date

June 26, 2007

Last Update Submit

June 26, 2007

Conditions

Non Alcoholic Steatohepatitis

Keywords

steatosis,fibrosis,diabetes,obesity

Outcome Measures

Primary Outcomes (1)

  • improvement in steatosis

Secondary Outcomes (1)

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

Interventions

rosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven NASH with steatosis \>= 20%
  • Increased serum ALT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 19877169DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty LiverFibrosisDiabetes MellitusObesity

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Vlad Ratziu, MD PhD

    Hôpital Pitié Salpêtrière, APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

January 1, 2003

Last Updated

June 27, 2007

Record last verified: 2007-06

Locations

FR(1)