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Treating Nonalcoholic Steatohepatitis With Pioglitazone

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ClinicalTrials.gov Identifier: NCT00062764
Recruitment Status : Completed
First Posted : June 13, 2003
Results First Posted : April 5, 2011
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Jay Hoofnagle, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis
Intervention Drug: Actos (Pioglitazone)
Enrollment 18
Recruitment Details Between March 2001 and April 2002, 25 patients suspected of having NASH were evaluated, and 18 were enrolled in the study after screening.
Pre-assignment Details  
Arm/Group Title Pioglitazone
Hide Arm/Group Description Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Pioglitazone
Hide Arm/Group Description Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
46  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
11
  61.1%
Male
7
  38.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic 3
White 13
Mixed 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Obesity Distribution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
BMI>30 11
BMI<=30 7
2-hr glucose diabetes mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
>200 mg/dL 2
<=200 mg/dL 16
2-hr glucose (Impaired glucose tolerance)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
140-199 mg/dL 11
other 7
Metabolic syndrome  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Yes 7
No 11
Fasting glucose  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 18 participants
110-125 mg/dL 2
other 16
1.Primary Outcome
Title Number of Patients With Improvement in Liver Histology
Hide Description A histological response was defined as a reduction in the NASH activity index by 3 points or more with improvements of at least 1 point each in steatosis, parenchymal inflammation, and hepatocellular injury.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone
Hide Arm/Group Description:
Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
12
2.Secondary Outcome
Title Number of Patients With Impaired Glucose Tolerance After Treatment
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone
Hide Arm/Group Description:
Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
6
3.Secondary Outcome
Title Mean Increase of Insulin Sensitivity Index
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone
Hide Arm/Group Description:
Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percentage
126  (78)
4.Secondary Outcome
Title Average Increase in Weight After Treatment
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone
Hide Arm/Group Description:
Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Overall Number of Participants Analyzed 18
Mean (Full Range)
Unit of Measure: kg
3.5
(-1.7 to 13.3)
5.Secondary Outcome
Title Mean BMI Change
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone
Hide Arm/Group Description:
Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: kg/m2
1.3  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone
Hide Arm/Group Description Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
All-Cause Mortality
Pioglitazone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Gastrointestinal disorders   
Worsened serum ALT levels *  0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pioglitazone
Affected / at Risk (%) # Events
Total   14/18 (77.78%)    
General disorders   
dizziness *  1/18 (5.56%)  1
Weight gain  13/18 (72.22%)  13
*
Indicates events were collected by non-systematic assessment

A major limitation of this study was the lack of a concurrently followed control group.

Another important shortcoming of this study was that patients were treated for 48 weeks only.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jay H. Hoofnagle, MD
Organization: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
Phone: 3014961333
EMail: hoofnaglej@extra.niddk.nih.gov
Layout table for additonal information
Responsible Party: Jay Hoofnagle, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00062764     History of Changes
Other Study ID Numbers: 030212
03-DK-0212
First Submitted: June 12, 2003
First Posted: June 13, 2003
Results First Submitted: March 1, 2011
Results First Posted: April 5, 2011
Last Update Posted: December 19, 2012