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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00063622
First received: July 1, 2003
Last updated: August 27, 2012
Last verified: August 2012

July 1, 2003
August 27, 2012
January 2005
June 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: baseline and 96 weeks ] [ Designated as safety issue: No ]
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.
Improvement in NASH activity defined by change in standardized scoring of liver biopsies at baseline and after 96 weeks of treatment.
Complete list of historical versions of study NCT00063622 on ClinicalTrials.gov Archive Site
  • Number of Participants With Improvement in Steatosis [ Time Frame: baseline and 96 weeks ] [ Designated as safety issue: No ]
    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 Lobular Inflammation [ Time Frame: baseline and 96 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Improvement in Hepatocellular Ballooning [ Time Frame: baseline and 96 weeks ] [ Designated as safety issue: No ]
    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 Improvement in Fibrosis [ Time Frame: baseline and 96 weeks ] [ Designated as safety issue: No ]
    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 Resolution of Definite Nonalcoholic Steatohepatitis [ Time Frame: baseline and 96 weeks ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

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).

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Liver Diseases
  • Drug: Pioglitazone
    30 mg daily
    Other Name: Actos
  • Dietary Supplement: Vitamin E
    800 IU daily
    Other Name: Nature Made
  • Drug: Matching placebo
    Daily
  • Active Comparator: 1
    Pioglitazone
    Intervention: Drug: Pioglitazone
  • Active Comparator: 2
    Vitamin E
    Intervention: Dietary Supplement: Vitamin E
  • Placebo Comparator: 3
    Placebo Pioglitazone or Placebo Vitamin E
    Intervention: Drug: Matching placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
September 2009
June 2009   (final data collection date for primary outcome measure)
  • Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
  • Age 18 years or older
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063622
NASH - ADULT (IND)
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP