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

This study is ongoing, but not recruiting participants.

First Received: July 1, 2003 Last Updated: December 14, 2007 History of Changes

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

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

Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Pioglitazone Pioglitazone hydrochloride Vitamin E Tocopherols Tocotrienol

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:

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

Additional Information:

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

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	NIDDK ( Patricia Robuck )
Study ID Numbers:	NASH - ADULT
Study First Received:	July 1, 2003
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00063622 History of Changes
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:

Liver Diseases
Tocopherol acetate
Antioxidants
Pioglitazone
Fatty Liver
Trace Elements
Alpha-Tocopherol

Tocopherols
Vitamin E
Hypoglycemic Agents
Digestive System Diseases
Vitamins
Tocotrienols
Micronutrients

Additional relevant MeSH terms:

Liver Diseases
Tocopherol acetate
Antioxidants
Pioglitazone
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Fatty Liver
Protective Agents

Pharmacologic Actions
Alpha-Tocopherol
Tocopherols
Vitamin E
Hypoglycemic Agents
Digestive System Diseases
Vitamins
Tocotrienols
Micronutrients

ClinicalTrials.gov processed this record on May 06, 2009