NCT00267670

Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH

The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Steatohepatitis
• Liver Diseases

Interventions

Type	Name	Description
DRUG	Pentoxifylline	400mg PO TID
DRUG	Placebo	1 pill PO TID

Timeline

• Start date: 2005-03-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2005-12-21
• Last updated: 2014-09-09
• Results posted: 2014-09-09

Locations

1 site across 1 country: United States