Liver Diseases Clinical Trial
Official title:
The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis (NASH)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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