Phase 3
N=247
Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Liver Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00063622 ↗Enrolled (actual)
247
Serious AEs
7.7%
Results posted
Aug 2012
Primary outcome: 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 participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pioglitazone (Drug); Vitamin E (Dietary_supplement); Matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Jun 2009
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 |
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
- 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.