Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH
|Nonalcoholic Steatohepatitis Liver Diseases||Drug: Pentoxifylline Drug: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis (NASH)|
- The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months. [ Time Frame: baseline and 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.
- The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH [ Time Frame: one year ]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.
- Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months [ Time Frame: baseline and one year ]Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.
- Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months [ Time Frame: one year ]
|Study Start Date:||March 2005|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
400mg PO TID
400mg PO TID
Other Name: Trental
Placebo Comparator: Placebo
1 pill PO TID
1 pill PO TID
Other Name: sugar pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267670
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Mary E Rinella, MD||Northwestern University|