IRB Number:

1591-03

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this research study is to look at a medication Etanercept in the acute inflammatory process in patients with alcoholic hepatitis and to test if this reduces inflammation in the liver.

Who is Eligible to Participate in the Study?

This study is being offered to patients who have been diagnosed with moderate or severe liver inflammation caused by alcohol.

Minimum Age:

18

What is Involved With this Study?

Participants will be put in one of two groups by chance. The two treatment plans consist of either study drug Etanercept or placebo (safe substance with no activity in humans). The medication are by injections under the skin twice weekly for three weeks with follow-up at 1, 3, & 6 months. Blood work will be obtained at some visits with injections and follow-up.

How long will the Study run?

The participant will receive treatment for 3 weeks, in or out-patient or possibly self injection if returns home address before end of treatment. There will be a 1, 3, and 6 follow-up.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Stephanie Johnson, RN at (507) 284-9709.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Temple

Last updated: 01/02/2007