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Trial record 18 of 277 for:    Non-alcoholic Steatohepatitis | United States

Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH

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ClinicalTrials.gov Identifier: NCT00267670
Recruitment Status : Completed
First Posted : December 21, 2005
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Mary Rinella, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Nonalcoholic Steatohepatitis
Liver Diseases
Interventions Drug: Pentoxifylline
Drug: Placebo
Enrollment 26
Recruitment Details From March 2005 to March 2008 patients were recruited through the Northwestern Memorial Faculty Foundation Hepatology Clinic.
Pre-assignment Details 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.
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description This group was given pentoxifylline 400mg thrice daily (tid) for 1 year This group was given a capsule identical to pentoxifylline that contained sucrose.
Period Title: Overall Study
Started 19 7
Completed 15 7
Not Completed 4 0
Arm/Group Title Pentoxifylline Placebo Total
Hide Arm/Group Description Patients in this group received pentoxifylline 400mg tid for 1 year. Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose. Total of all reporting groups
Overall Number of Baseline Participants 19 7 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 7 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
7
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 7 participants 26 participants
46  (10) 53  (8) 49.5  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 7 participants 26 participants
Female
12
  63.2%
3
  42.9%
15
  57.7%
Male
7
  36.8%
4
  57.1%
11
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 7 participants 26 participants
19 7 26
1.Primary Outcome
Title The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.
Hide Description 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.
Time Frame baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description:
Patients in this group received pentoxifylline 400mg tid for 1 year.
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
Overall Number of Participants Analyzed 19 7
Measure Type: Number
Unit of Measure: participants
19 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline, Placebo
Comments Sample size estimates were based on 30% reduction in ALT in the treatment group & 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), & a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, & accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH
Hide Description 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.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat with last observation carried forward
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description:
Patients in this group received pentoxifylline 400mg tid for 1 year.
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
Overall Number of Participants Analyzed 19 7
Mean (Standard Error)
Unit of Measure: pg/dL
-117.9  (109.5) 18.3  (64.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline, Placebo
Comments Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months
Hide Description Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.
Time Frame baseline and one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description:
Patients in this group received pentoxifylline 400mg tid for 1 year.
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
Overall Number of Participants Analyzed 19 7
Mean (Standard Error)
Unit of Measure: ng/mL
0.78  (0.07) 0.78  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description:
Patients in this group received pentoxifylline 400mg tid for 1 year.
Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
Overall Number of Participants Analyzed 19 7
Mean (Standard Error)
Unit of Measure: ug/mL
0.4  (0.3) 0.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events data were collected for 1 year for the duration of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description Patients in this group received pentoxifylline 400mg tid for 1 year. Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
All-Cause Mortality
Pentoxifylline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pentoxifylline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pentoxifylline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/7 (0.00%) 
The most significant limitation of this study is the small sample size, thus the lack of statistical significance may be due to low power.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mary E. Rinella, MD
Organization: Northwestern University
Phone: 312-503-4592
Responsible Party: Mary Rinella, Northwestern University
ClinicalTrials.gov Identifier: NCT00267670     History of Changes
Other Study ID Numbers: IRB # 1347-001
GCRC Protocol #891 ( Other Identifier: Northwestern University Clinical Research Center )
First Submitted: December 12, 2005
First Posted: December 21, 2005
Results First Submitted: January 13, 2011
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014