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Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis (URSONASH)

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ursodesoxycholic acid
Sponsored by
Axcan Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Serum Levels of ALAT Transaminases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • La Pitié Salpétrière Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2007
Last Updated
February 2, 2009
Sponsor
Axcan Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00470171
Brief Title
Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis
Acronym
URSONASH
Official Title
Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Axcan Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serum Levels of ALAT Transaminases, Serum Markers for Fibrosis and Hepatic Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ursodesoxycholic acid
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlad Ratziu, M.D., Ph.D.
Organizational Affiliation
La Pitié Salpétrière Hospital, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Pitié Salpétrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

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Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis

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