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

Purpose

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).

Condition	Intervention	Phase
Liver Diseases	Drug: Pioglitazone Dietary Supplement: Vitamin E Drug: Matching placebo	Phase III

MedlinePlus related topics:

Liver Diseases

ChemIDplus related topics:

Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

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 Measures:

Liver fibrosis [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment:	247
Study Start Date:	November 2004
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
1: Active Comparator Pioglitazone	Drug: Pioglitazone 30 mg daily
2: Active Comparator Vitamin E	Dietary Supplement: Vitamin E 800 IU daily
3: Placebo Comparator Placebo Pioglitazone or Placebo Vitamin E	Drug: Matching placebo Daily

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
Age 18 years or older

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063622

Locations


United States, California
	University of California, San Diego
	San Diego, California, United States, 92103
	University of California, San Francisco
	San Francisco, California, United States, 94143

United States, Indiana
	Indiana University
	Indianapolis, Indiana, United States, 46202

United States, Missouri
	St. Louis University
	St. Louis, Missouri, United States, 63110

United States, North Carolina
	Duke University Medical Center
	Durham, North Carolina, United States, 27710

United States, Ohio
	Case Western Reserve University
	Cleveland, Ohio, United States, 44109

United States, Virginia
	Virginia Commonwealth University
	Richmond, Virginia, United States, 23298

United States, Washington
	University of Washington
	Seattle, Washington, United States, 98195

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

National Institute of Diabetes and Digestive and Kidney Diseases This link exits the ClinicalTrials.gov site

Responsible Party:	NIDDK ( Patricia Robuck )
Study ID Numbers:	NASH - ADULT
First Received:	July 1, 2003
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00063622
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Non alcoholic steatohepatitis

Steatohepatitis

Study placed in the following topic categories:

Tocopherols

Tocopherol acetate

Vitamin E

Liver Diseases

Digestive System Diseases

Pioglitazone

Alpha-Tocopherol

Additional relevant MeSH terms:

Hypoglycemic Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Growth Substances

Vitamins

Physiological Effects of Drugs

Micronutrients

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00063622