A Phase 2/3 interventional study of Pentoxifylline and Placebo in Nonalcoholic Steatohepatitis and Liver Diseases, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-09.
Sponsored by Northwestern University · Phase 2/3, Interventional, and Treatment
The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.
This is an investigational study looking at subjects who have been diagnosed with nonalcoholic steatohepatitis (NASH) or 'fatty liver disease'. There is currently no FDA approved available treatment for NASH. The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH. The effectiveness of this drug will be determined by taking blood samples and a liver biopsy. To determine if there is any effect of the medication, two-thirds of the patients participating in the study will receive pentoxifylline and one-third will receive placebo (sugar pill). Thus, an individual's chance of receiving the drug is 67%. In addition to receiving a study drug (placebo or pentoxifylline) the subjects will be encouraged to achieve modest weight loss (\~1-2 lbs/week) via low-fat diet and exercise.
The drug (Pentoxifylline) being studied is not approved for use in people who have NASH. Pentoxifylline is considered experimental in this study. Pentoxifylline has been safely used for the treatment of other medical conditions such as alcohol related liver disease and poor circulation. Pentoxifylline is a pill which is taken three times a day.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 26 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
Exclusion Criteria:
400mg PO TID
Drug: Pentoxifylline
1 pill PO TID
Drug: Placebo
400mg PO TID
Also known as: Trental
1 pill PO TID
Also known as: sugar pill
The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.
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
The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH
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
Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months
Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.
Time frame: baseline and one year
Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months
Time frame: one year
From March 2005 to March 2008 patients were recruited through the Northwestern Memorial Faculty Foundation Hepatology Clinic.
| Milestone | Pentoxifylline | Placebo |
|---|---|---|
| Started | 19 | 7 |
| Completed | 15 | 7 |
| Not completed | 4 | 0 |
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.
| participants | Pentoxifylline | Placebo |
|---|---|---|
| The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months. | 19 | 7 |
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.
| pg/dL | Pentoxifylline | Placebo |
|---|---|---|
| The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH | -117.9 ± 109.5 | 18.3 ± 64.4 |
Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.
| ng/mL | Pentoxifylline | Placebo |
|---|---|---|
| Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months | 0.78 ± 0.07 | 0.78 ± 0.08 |
| ug/mL | Pentoxifylline | Placebo |
|---|---|---|
| Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months | 0.4 ± 0.3 | 0.8 ± 0.4 |
Collected over Adverse events data were collected for 1 year for the duration of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pentoxifylline | — | 0/19 (0%) | 0/19 (0%) |
| Placebo | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 7 | 26 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| Mean | 46 ± 10 | 53 ± 8 | 49.5 ± 10 |
| Sex: Female, Male(Participants) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| Female | 12 | 3 | 15 |
| Male | 7 | 4 | 11 |
| Region of Enrollment(participants) | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| United States | 19 | 7 | 26 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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