A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
NCT ID: NCT00492700
Last Updated: 2007-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2003-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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rosiglitazone
Eligibility Criteria
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Inclusion Criteria
* Increased serum ALT
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Association pour la Recherche sur les Maladies Hépatiques Virales
OTHER
Principal Investigators
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Vlad Ratziu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Pitié Salpêtrière, APHP
Locations
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Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière
Paris, , France
Countries
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References
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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.
Other Identifiers
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LIDO-Trials-01
Identifier Type: -
Identifier Source: org_study_id