Trial Outcomes & Findings for Treating Nonalcoholic Steatohepatitis With Pioglitazone (NCT NCT00062764)
NCT ID: NCT00062764
Last Updated: 2012-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
48 weeks
Results posted on
2012-12-19
Participant Flow
Between March 2001 and April 2002, 25 patients suspected of having NASH were evaluated, and 18 were enrolled in the study after screening.
Participant milestones
| Measure |
Pioglitazone
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 Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Nonalcoholic Steatohepatitis With Pioglitazone
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=18 Participants
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.
|
|---|---|
|
Age Continuous
|
46 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Obesity Distribution
BMI>30
|
11 participants
n=5 Participants
|
|
Obesity Distribution
BMI<=30
|
7 participants
n=5 Participants
|
|
2-hr glucose diabetes mellitus
>200 mg/dL
|
2 participants
n=5 Participants
|
|
2-hr glucose diabetes mellitus
<=200 mg/dL
|
16 participants
n=5 Participants
|
|
2-hr glucose (Impaired glucose tolerance)
140-199 mg/dL
|
11 participants
n=5 Participants
|
|
2-hr glucose (Impaired glucose tolerance)
other
|
7 participants
n=5 Participants
|
|
Metabolic syndrome
Yes
|
7 participants
n=5 Participants
|
|
Metabolic syndrome
No
|
11 participants
n=5 Participants
|
|
Fasting glucose
110-125 mg/dL
|
2 participant
n=5 Participants
|
|
Fasting glucose
other
|
16 participant
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksA 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.
Outcome measures
| Measure |
Pioglitazone
n=18 Participants
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.
|
|---|---|
|
Number of Patients With Improvement in Liver Histology
|
12 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Pioglitazone
n=18 Participants
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.
|
|---|---|
|
Number of Patients With Impaired Glucose Tolerance After Treatment
|
6 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Pioglitazone
n=18 Participants
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.
|
|---|---|
|
Mean Increase of Insulin Sensitivity Index
|
126 percentage
Standard Deviation 78
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Pioglitazone
n=18 Participants
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.
|
|---|---|
|
Average Increase in Weight After Treatment
|
3.5 kg
Interval -1.7 to 13.3
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Pioglitazone
n=18 Participants
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.
|
|---|---|
|
Mean BMI Change
|
1.3 kg/m2
Standard Deviation 1.7
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone
n=18 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Worsened serum ALT levels
|
0.00%
0/18
|
Other adverse events
| Measure |
Pioglitazone
n=18 participants at risk
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.
|
|---|---|
|
General disorders
dizziness
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Weight gain
|
72.2%
13/18 • Number of events 13
|
Additional Information
Jay H. Hoofnagle, MD
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
Phone: 3014961333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place