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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00063622
Other study ID # NASH - ADULT (IND)
Secondary ID U01DK061730
Status Completed
Phase Phase 3
First received July 1, 2003
Last updated March 12, 2018
Start date January 2005
Est. completion date September 2009

Study information

Verified date August 2012
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date September 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.

- Age 18 years or older

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pioglitazone
30 mg daily
Dietary Supplement:
Vitamin E
800 IU daily
Drug:
Matching placebo
Daily

Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States Indiana University Indianapolis Indiana
United States Virginia Commonwealth University Richmond Virginia
United States St. Louis University Saint Louis Missouri
United States University of California, San Diego San Diego California
United States University of California, San Francisco San Francisco California
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score. baseline and 96 weeks
Secondary Number of Participants With Improvement in Steatosis Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis. baseline and 96 weeks
Secondary Number of Participants With Improvement in Lobular Inflammation Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation. baseline and 96 weeks
Secondary Number of Participants With Improvement in Hepatocellular Ballooning Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning. baseline and 96 weeks
Secondary Number of Participants With Improvement in Fibrosis Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis. baseline and 96 weeks
Secondary Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis. baseline and 96 weeks
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