A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis (FLIRT)
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ClinicalTrials.gov Identifier: NCT00492700 |
Recruitment Status :
Completed
First Posted : June 27, 2007
Last Update Posted : June 27, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Alcoholic Steatohepatitis | Drug: rosiglitazone | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis |
Study Start Date : | January 2003 |
- improvement in steatosis
- improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492700
France | |
Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière | |
Paris, France, 75013 |
Principal Investigator: | Vlad Ratziu, MD PhD | Hôpital Pitié Salpêtrière, APHP |
ClinicalTrials.gov Identifier: | NCT00492700 |
Other Study ID Numbers: |
LIDO-Trials-01 |
First Posted: | June 27, 2007 Key Record Dates |
Last Update Posted: | June 27, 2007 |
Last Verified: | June 2007 |
steatosis, fibrosis, diabetes, obesity |
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases |
Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |