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

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Descriptive Information Fields
Brief Title ^†	Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
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)
Brief 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).
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).
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	Improvement in NASH activity defined by change in standardized scoring of liver biopsies at baseline and after 96 weeks of treatment. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†	Liver fibrosis [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Condition ^†	Liver Diseases
Intervention ^†	Drug: Pioglitazone Dietary Supplement: Vitamin E Drug: Matching placebo
MEDLINE PMIDs
Links	National Institute of Diabetes and Digestive and Kidney Diseases

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	247
Start Date ^†	November 2004
Completion Date	September 2009
Eligibility Criteria ^†	Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization. Age 18 years or older
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00063622
Organization ID	NASH - ADULT
Secondary IDs ^††
Study Sponsor ^†	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	December 2007
First Received Date ^†	July 1, 2003
Last Updated Date	December 14, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.