Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS) (PIVENS)
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| ClinicalTrials.gov Identifier: NCT00063622 |
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Recruitment Status :
Completed
First Posted : July 3, 2003
Results First Posted : August 1, 2012
Last Update Posted : April 6, 2018
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Liver Diseases | Drug: Pioglitazone Dietary Supplement: Vitamin E Drug: Matching placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 247 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, 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) |
| Study Start Date : | January 2005 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | September 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Pioglitazone
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Drug: Pioglitazone
30 mg daily
Other Name: Actos |
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Active Comparator: 2
Vitamin E
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Dietary Supplement: Vitamin E
800 IU daily
Other Name: Nature Made |
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Placebo Comparator: 3
Placebo Pioglitazone or Placebo Vitamin E
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Drug: Matching placebo
Daily |
Primary Outcome Measures :
- Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. [ Time Frame: baseline and 96 weeks ]Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.
Secondary Outcome Measures :
- Number of Participants With Improvement in Steatosis [ Time Frame: baseline and 96 weeks ]Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis.
- Number of Participants With Improvement in Lobular Inflammation [ Time Frame: baseline and 96 weeks ]Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation.
- Number of Participants With Improvement in Hepatocellular Ballooning [ Time Frame: baseline and 96 weeks ]Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning.
- Number of Participants With Improvement in Fibrosis [ Time Frame: baseline and 96 weeks ]Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis.
- Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis [ Time Frame: baseline and 96 weeks ]The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Saint 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)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00063622 |
| Other Study ID Numbers: |
NASH - ADULT (IND) U01DK061730 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 3, 2003 Key Record Dates |
| Results First Posted: | August 1, 2012 |
| Last Update Posted: | April 6, 2018 |
| Last Verified: | August 2012 |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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Non alcoholic steatohepatitis Steatohepatitis |
Additional relevant MeSH terms:
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Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases Vitamin E Pioglitazone Vitamins |
Micronutrients Physiological Effects of Drugs Hypoglycemic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |