MedTrace Logo

Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis

NCT00470171 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2009-02-03

No results posted yet for this study

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.

Conditions

  • Serum Levels of ALAT Transaminases
  • Serum Markers for Fibrosis and Hepatic Inflammation

Interventions

DRUG

Ursodesoxycholic acid

Sponsors & Collaborators

  • Axcan Pharma

    lead INDUSTRY

Principal Investigators

  • Vlad Ratziu, M.D., Ph.D. · La Pitié Salpétrière Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00470171 on ClinicalTrials.gov