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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00063622
First received: July 1, 2003
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Liver Diseases
Interventions: Drug: Pioglitazone
Dietary Supplement: Vitamin E
Drug: Matching placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
PIVENS enrollment started in January 2005 and ended in January 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 339 patients were registered and screened for PIVENS trial, 92 of whom (27%) were found ineligible. The failure to meet histological entry criteria and fasting blood glucose >125 mg/dL were the most frequent reasons for ineligibility.

Reporting Groups
  Description
Pioglitazone Pioglitazone at a dose of 30 mg daily
Vitamin E Vitamin E at a dose of 800 IU daily
Placebo Placebo Pioglitazone and Placebo Vitamin E

Participant Flow:   Overall Study
    Pioglitazone     Vitamin E     Placebo  
STARTED     80     84     83  
COMPLETED     70 [1]   80 [1]   72 [1]
NOT COMPLETED     10     4     11  
[1] All randomized patients were included in analysis of primary outcome



  Baseline Characteristics
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Reporting Groups
  Description
Pioglitazone Pioglitazone at a dose of 30 mg daily
Vitamin E Vitamin E at a dose of 800 IU daily
Placebo Placebo Pioglitazone and Placebo Vitamin E
Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Vitamin E     Placebo     Total  
Number of Participants  
[units: participants]
 		  80     84     83     247  
Age  
[units: years]
Mean ± Standard Deviation 		  47.0  ± 12.6     46.6  ± 12.1     45.4  ± 11.2     46.3  ± 11.9  
Gender  
[units: participants]
 		       
Female     47     52     48     147  
Male     33     32     35     100  
Region of Enrollment  
[units: participants]
 		       
United States     80     84     83     247  
Total nonalcoholic fatty liver disease (NAFLD) activity score [1]
[units: scores on a scale]
Mean ± Standard Deviation 		  5.0  ± 1.4     5.1  ± 1.4     4.8  ± 1.4     4.9  ± 1.4  
[1] 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).



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Improvement in Steatosis   [ Time Frame: baseline and 96 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Improvement in Lobular Inflammation   [ Time Frame: baseline and 96 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Improvement in Hepatocellular Ballooning   [ Time Frame: baseline and 96 weeks ]
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5.  Secondary:   Number of Participants With Improvement in Fibrosis   [ Time Frame: baseline and 96 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis   [ Time Frame: baseline and 96 weeks ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Arun J. Sanyal
Organization: Virginia Commonwealth University
e-mail: asanyal@mcvh-vcu.edu


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

Publications automatically indexed to this study:


Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00063622     History of Changes
Other Study ID Numbers: NASH - ADULT (IND)
Study First Received: July 1, 2003
Results First Received: June 14, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration