- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00492700
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis (FLIRT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Paris, France, 75013
- Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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improvement in steatosis
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Secondary Outcome Measures
Outcome Measure |
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improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
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Collaborators and Investigators
Investigators
- Principal Investigator: Vlad Ratziu, MD PhD, Hôpital Pitié Salpêtrière, APHP
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIDO-Trials-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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