Trial Outcomes & Findings for Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH (NCT NCT00267670)
NCT ID: NCT00267670
Last Updated: 2014-09-09
Results Overview
The primary goal of the study was to determine whether pentoxifylline (PTX) therapy improved serum ALT (\> or = 30% change from baseline to month 12) compared to placebo.
COMPLETED
PHASE2/PHASE3
26 participants
baseline and 12 months
2014-09-09
Participant Flow
From March 2005 to March 2008 patients were recruited through the Northwestern Memorial Faculty Foundation Hepatology Clinic.
Subjects were excluded from the study if they had evidence of another form of liver disease or if they were HIV positive, pregnant or had evidence of ongoing alcohol consumption exceeding 20g(males) and 10g(females)daily. Furthermore, subjects were excluded if they were taking drugs known to cause steatohepatitis.
Participant milestones
| Measure |
Pentoxifylline
This group was given pentoxifylline 400mg thrice daily (tid) for 1 year
|
Placebo
This group was given a capsule identical to pentoxifylline that contained sucrose.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
7
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH
Baseline characteristics by cohort
| Measure |
Pentoxifylline
n=19 Participants
Patients in this group received pentoxifylline 400mg tid for 1 year.
|
Placebo
n=7 Participants
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 10 • n=5 Participants
|
53 years
STANDARD_DEVIATION 8 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
7 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: The primary analysis was done as intention to treat. A secondary analysis was performed per protocol and there were no differences between the two analyses. Intention to treat results are reported.
The primary goal of the study was to determine whether pentoxifylline (PTX) therapy improved serum ALT (\> or = 30% change from baseline to month 12) compared to placebo.
Outcome measures
| Measure |
Pentoxifylline
n=19 Participants
Patients in this group received pentoxifylline 400mg tid for 1 year.
|
Placebo
n=7 Participants
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
|
|---|---|---|
|
The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.
|
19 participants
|
7 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Intention to Treat with last observation carried forward
The mean change from baseline to month 12 in proinflammatory cytokines (such as TNF-α) and gene expresssion were the secondary endpoints and were analyzed with the same analysis of covariance model and summary statistics specified for the primary endpoint. Differences were regarded as statistically significant when P \< 0.05. The results for TNF-α are reported here. Interleukin-6 \[IL-6\], IL-10) and expression of TNF-alpha Receptors (p55 and p75) had insufficient data for statistical analysis.
Outcome measures
| Measure |
Pentoxifylline
n=19 Participants
Patients in this group received pentoxifylline 400mg tid for 1 year.
|
Placebo
n=7 Participants
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
|
|---|---|---|
|
The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH
|
-117.9 pg/dL
Standard Error 109.5
|
18.3 pg/dL
Standard Error 64.4
|
SECONDARY outcome
Timeframe: baseline and one yearValues represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.
Outcome measures
| Measure |
Pentoxifylline
n=19 Participants
Patients in this group received pentoxifylline 400mg tid for 1 year.
|
Placebo
n=7 Participants
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
|
|---|---|---|
|
Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months
|
0.78 ng/mL
Standard Error 0.07
|
0.78 ng/mL
Standard Error 0.08
|
SECONDARY outcome
Timeframe: one yearOutcome measures
| Measure |
Pentoxifylline
n=19 Participants
Patients in this group received pentoxifylline 400mg tid for 1 year.
|
Placebo
n=7 Participants
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
|
|---|---|---|
|
Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months
|
0.4 ug/mL
Standard Error 0.3
|
0.8 ug/mL
Standard Error 0.4
|
Adverse Events
Pentoxifylline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place