Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Diseases
Intervention: Pioglitazone (Drug); Vitamin E (Dietary Supplement); Matching placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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).
Clinical Details
Official title: Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Improvement in NASH activity defined by change in standardized scoring of liver biopsies at baseline and after 96 weeks of treatment.
Secondary outcome: Liver fibrosis
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- Histologic evidence of NASH based on a liver biopsy obtained within 6 months of
randomization.
- Age 18 years or older
Locations and Contacts
University of California, San Diego, San Diego, California 92103, United States
University of California, San Francisco, San Francisco, California 94143, United States
Indiana University, Indianapolis, Indiana 46202, United States
St. Louis University, St. Louis, Missouri 63110, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Case Western Reserve University, Cleveland, Ohio 44109, United States
Virginia Commonwealth University, Richmond, Virginia 23298, United States
University of Washington, Seattle, Washington 98195, United States
Additional Information
National Institute of Diabetes and Digestive and Kidney Diseases
Starting date: November 2004
Ending date: September 2009
Last updated: December 14, 2007
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