Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
- Conditions
- Liver Diseases
- Interventions
- Registration Number
- NCT00063622
- Brief 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Matching placebo Placebo Pioglitazone or Placebo Vitamin E 2 Vitamin E Vitamin E 1 Pioglitazone Pioglitazone
- Primary Outcome Measures
Name Time Method 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. baseline and 96 weeks 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Improvement in Fibrosis baseline and 96 weeks 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.
Number of Participants With Improvement in Steatosis baseline and 96 weeks 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.
Number of Participants With Improvement in Hepatocellular Ballooning baseline and 96 weeks 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.
Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis baseline and 96 weeks 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.
Number of Participants With Improvement in Lobular Inflammation baseline and 96 weeks 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.
Trial Locations
- Locations (8)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Washington
🇺🇸Seattle, Washington, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of California, San Diego
🇺🇸San Diego, California, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States