Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
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 patients who have been diagnosed with non-alcoholic steatohepatitis.
The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment
associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in
transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is
defined as a significantly larger decrease in average ALAT levels between the time of
inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as
compared to the placebo group.
The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take
place at the end of the 12th month of treatment.