Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

Last updated: March 12, 2018
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Completed

Phase

3

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT00063622
NASH - ADULT (IND)
U01DK061730
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Eligibility Criteria

Inclusion

  • Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.

  • Age 18 years or older

Study Design

Total Participants: 247
Study Start date:
January 01, 2005
Estimated Completion Date:
September 30, 2009

Study Description

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Connect with a study center

  • University of California, San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • St. Louis University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • St. Louis University

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

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