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

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

This study has been completed.

First Received: June 26, 2007 No Changes Posted

Sponsored by:	Association pour la Recherche sur les Maladies Hépatiques Virales
Information provided by:	Association pour la Recherche sur les Maladies Hépatiques Virales
ClinicalTrials.gov Identifier:	NCT00492700

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 II

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

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

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

Study ID Numbers:	LIDO-Trials-01
Study First Received:	June 26, 2007
Last Updated:	June 26, 2007
ClinicalTrials.gov Identifier:	NCT00492700 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Association pour la Recherche sur les Maladies Hépatiques Virales:

steatosis,
fibrosis,
diabetes,
obesity

Study placed in the following topic categories:

Obesity
Liver Diseases
Hypoglycemic Agents
Digestive System Diseases

Fibrosis
Diabetes Mellitus
Fatty Liver
Rosiglitazone

Additional relevant MeSH terms:

Liver Diseases
Hypoglycemic Agents
Digestive System Diseases
Physiological Effects of Drugs

Fatty Liver
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009