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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases Vitamin E

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

U.S. FDA Resources

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
Study Completion Date:	September 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Pioglitazone	Drug: Pioglitazone 30 mg daily Other Name: Actos
Active Comparator: 2 Vitamin E	Dietary Supplement: Vitamin E 800 IU daily Other Name: Nature Made
Placebo Comparator: 3 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

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 ClinicalTrials.gov Identifier (NCT Number):

Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. Epub 2010 Apr 28.

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:	Patricia Robuck, NIDDK
ClinicalTrials.gov Identifier:	NCT00063622 History of Changes
Other Study ID Numbers:	NASH - ADULT (IND)
Study First Received:	July 1, 2003
Last Updated:	May 2, 2011
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

Additional relevant MeSH terms:

Liver Diseases
Fatty Liver
Digestive System Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Pioglitazone

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Hypoglycemic Agents

ClinicalTrials.gov processed this record on February 09, 2012