Phase 3
Completed N=247
Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Source: ClinicalTrials.gov NCT00063622 ↗Enrolled (actual)
247
Serious AEs
7.7%
Results posted
Aug 2012
Primary outcomePrimary: 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. — 27; 36; 16 participants — p=0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
27; 36; 16 | 0.001 sig |
| SECONDARY Number of Participants With Improvement in Steatosis |
48; 43; 22 | 0.005 sig |
| SECONDARY Number of Participants With Improvement in Lobular Inflammation |
41; 43; 25 | 0.02 sig |
| SECONDARY Number of Participants With Improvement in Hepatocellular Ballooning |
31; 40; 21 | 0.01 sig |
| SECONDARY Number of Participants With Improvement in Fibrosis |
31; 33; 22 | 0.24 |
| SECONDARY Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis |
33; 29; 15 | 0.05 |
Eligibility Criteria
- Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
- Age 18 years or older
Data sourced from ClinicalTrials.gov (NCT00063622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.