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

Tracking Information
First Received Date ^ICMJE	July 1, 2003
Last Updated Date	December 14, 2007
Start Date ^ICMJE	November 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: December 14, 2007)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Improvement in NASH activity defined by change in standardized scoring of liver biopsies at baseline and after 96 weeks of treatment.
Change History	Complete list of historical versions of study NCT00063622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 14, 2007)	Liver fibrosis [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Liver Diseases
Intervention ^ICMJE	Drug: Pioglitazone Dietary Supplement: Vitamin E Drug: Matching placebo
Study Arms / Comparison Groups	Active Comparator: Pioglitazone Active Comparator: Vitamin E Placebo Comparator: Placebo Pioglitazone or Placebo Vitamin E
Publications *	Chalasani NP, Sanyal AJ, Kowdley KV, Robuck PR, Hoofnagle J, Kleiner DE, Unalp A, Tonascia J; NASH CRN Research Group. Pioglitazone versus vitamin E versus placebo for the treatment of non-diabetic patients with non-alcoholic steatohepatitis: PIVENS trial design. Contemp Clin Trials. 2009 Jan;30(1):88-96. Epub 2008 Sep 10.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	247
Estimated Completion Date	September 2009
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063622
Responsible Party	Patricia Robuck, NIDDK
Study ID Numbers ^ICMJE	NASH - ADULT
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP