Conditions: Nonalcoholic Steatohepatitis Liver Diseases
Keywords: Fatty Liver Disease Liver NASH Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease (NAFLD) Pentoxifylline
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief summary:
The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.

Detailed description:
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.

Arms:
arm 1: 400mg PO TID arm 2: 1 pill PO TID

Interventions: intervention 1: Pentoxifylline intervention 2: Placebo
Intervention descriptions: intervention 1: 400mg PO TID intervention 2: 1 pill PO TID

Protocol document: