The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis (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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To assess the effect of pentoxifylline on serum markers of liver inflammation (ALT) in patients with NASH
Mary E Rinella, MD
United States: Food and Drug Administration
IRB # 1347-001
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