At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 247 enrolled
Drug / intervention
Pioglitazone +2 moredrug
Likely dose
Pioglitazone 30 mg daily; Vitamin E 800 IU dailyAI-extracted
Key inclusion· 2
- ✓Histologic evidence of NASH based on liver biopsy obtained within 6 months of randomization
- ✓Age 18 years or older
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jul 3, 2003·Updated Apr 6, 2018
In Brief
A Phase 3 clinical trial evaluating Pioglitazone, Vitamin E, and 1 other intervention for Liver Diseases. Completed, enrolled 247 participants across 8 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Diseases
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2003
Enrollment StartJan 2005
Primary CompletionJun 2009
Study CompletionSep 2009
TodayJul 2026
First PostedJul 3, 2003
Enrollment StartJan 1, 2005
Primary CompletionJun 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 23.0 years ago
Interventions
Pioglitazonedrug
30 mg daily
Vitamin Edietary
800 IU daily
Matching placebodrug
Daily