Status:
COMPLETED
Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis
Lead Sponsor:
Axcan Pharma
Conditions:
Serum Levels of ALAT Transaminases
Serum Markers for Fibrosis and Hepatic Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patie...
Eligibility Criteria
Inclusion
- Greater than 18 years of age.
- Hepatic biopsy consistent with non-alcoholic steatohepatitis: presence of \>20% steatosis associated with hepatocyte swelling and/or intralobular necrosis within the last 18 months.
- Serum levels of ALAT and/or ASAT \> 50 UI/L at the time of screening (with at least 3 elevated transaminase values within the last 12 months).
Exclusion
- Hepatic biopsy not performed within the last 18 months.
- A single normal transaminase value within the last 12 months.
- Treatment with ursodesoxycholic acid within the last 12 months.
- Loss of more than 15% body weight between the time of the liver biopsy and the time of screening.
- Alcohol consumption of \>20 g/day for women and \> 30 g/day for men
- Hepatitis from other causes: chronic viral hepatitis B or C, elevated ferritin levels associated with C282Y homozygosity, primary biliary cirrhosis, primary sclerosing cholangitis, well documented auto-immune hepatitis (specific autoantibodies, hypergammaglobulinemia, consistent histologic changes), alpha1 antitrypsin deficiency, Wilson's disease, HIV infection.
- NASH from secondary causes: long term amiodarone administration, corticosteroid therapy, anti-obesity surgery within the last 2 years, tamoxifen.
- Child's type B or C cirrhosis.
- Presence of hepatocellular carcinoma.
- Treatment with rosiglitazone or pioglitazone currently or during the 3 preceding years, treatment with Vitamin E within the 6 months prior to screening.
- Women who are pregnant or nursing.
- Unavailability of hepatic biopsy slides for centralized interpretation.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00470171
Start Date
October 1 2005
End Date
November 1 2008
Last Update
February 3 2009
Active Locations (1)
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1
La Pitié Salpétrière Hospital
Paris, France, 75013