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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00267670 |
The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.
Condition | Intervention | Phase |
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Nonalcoholic Steatohepatitis Liver Diseases |
Drug: Pentoxifylline |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis (NASH) |
Estimated Enrollment: | 30 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2008 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
Exclusion Criteria:
Contact: Robin R Smolak, BA | 312-503-0623 ext 0623 | r-smolak@northwestern.edu |
Contact: Mary E Rinella, MD | 312-503-4592 ext 4592 | m-rinella@northwestern.edu |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Mary E Rinella, MD | |
Sub-Investigator: Richard M Green, MD | |
Sub-Investigator: Sean WP Koppe, MD |
Principal Investigator: | Mary E Rinella, MD | Northwestern University |
Study ID Numbers: | IRB # 1347-001, GCRC Protcol #891 |
Study First Received: | December 12, 2005 |
Last Updated: | February 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00267670 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Fatty Liver Disease Liver NASH Nonalcoholic Steatohepatitis |
NAFLD Nonalcoholic Fatty Liver Disease Pentoxifylline |
Vasodilator Agents Radiation-Protective Agents Liver Diseases Antioxidants Phosphodiesterase Inhibitors Non-alcoholic Steatohepatitis (NASH) |
Digestive System Diseases Platelet Aggregation Inhibitors Fatty Liver Cardiovascular Agents Pentoxifylline |
Vasodilator Agents Liver Diseases Radiation-Protective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fatty Liver Enzyme Inhibitors |
Cardiovascular Agents Protective Agents Pentoxifylline Pharmacologic Actions Digestive System Diseases Phosphodiesterase Inhibitors Therapeutic Uses Free Radical Scavengers Platelet Aggregation Inhibitors |