A Controlled Trial of Etanercept in the Treatment of Alcoholic Hepatitis
IRB#: 0505M70146
Trial Status: Open for enrollment
Phase: II
Sponsor: NIH
Why is this study being done? Etanercept has been used in a small research study to treat alcoholic hepatitis. The researchers want to do this study to find out what effects (good or bad) that etanercept
has on patients and their hepatitis.
Who is eligible to participate in the study? _
Patients diagnosed with moderate or severe alcoholic hepatitis (inflammation in the liver).
If you are currently taking Pentoxifylline or corticosteroids, you cannot be in this study.
Minimum age: 18 years
What is involved in the study?
At the screening visit you will have blood drawn for tests (including a pregnancy test), get a physical exam, and a member of the study staff will review your medications. You might need to have a liver biopsy if the study doctor feels it is necessary. The screening visit could last up to 3 hours. You will be randomized (like the flip of a coin) to get the study drug or placebo (like a sugar pill) and will not be told which one you are getting. The study doctor and his research staff will not know what you are getting either. You will get the study drug twice a week for 3 weeks. The study drug is injected under your skin. If you are in the hospital the nursing staff will give it to you. If you are not in the hospital, you will be taught how to do the injection yourself.
On days 1, 4, 11 and 15, you will come for a study visit and review your medications with the study staff. On days 8 and 18 you will have blood drawn, have a physical examination and review your medications with a member of the study staff. One month, 3 months and 6 months after your last dose of study drug you will come for a study visit and have blood drawn and review your medications with a member of the study staff. Each of these visits could last up to 2 hours.
How long will the study run?
Your participation will be up to 6 months.
Who can I contact to find out more about this trial?
Kathy Duderstadt, R.N. (612) 626-3421
What are the locations of this trial?
University of Minnesota Medical Center, Fairview – Minneapolis, Minnesota
Rochester, Minnesota
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