Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis - Full Text View

Sponsor:	Axcan Pharma
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00470171

Purpose

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.

Condition	Intervention	Phase
Serum Levels of ALAT Transaminases Serum Markers for Fibrosis and Hepatic Inflammation	Drug: Ursodesoxycholic acid	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis

Resource links provided by NLM:

Drug Information available for: Ursodeoxycholic acid

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

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.

Estimated Enrollment:	98
Study Start Date:	October 2005
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470171

Locations

France
La Pitié Salpétrière Hospital
Paris, France, 75013

Sponsors and Collaborators

Axcan Pharma

Investigators

Principal Investigator:

Vlad Ratziu, M.D., Ph.D.

La Pitié Salpétrière Hospital, Paris, France

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00470171 History of Changes
Other Study ID Numbers:	URSONASH05-01, EudraCT n° : 2005-001931-31
Study First Received:	May 4, 2007
Last Updated:	February 2, 2009
Health Authority:	France : Health French Agency AFSSAPS

Additional relevant MeSH terms:

Fibrosis
Inflammation
Fatty Liver
Pathologic Processes
Liver Diseases
Digestive System Diseases

Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012