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

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

This study is ongoing, but not recruiting participants.
Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This Tabular View shows the required WHO registration data elements as marked by ^†

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.