Drug Study for Hepatic Encephalopathy Patients

Study Summary

The University of Chicago and Dr. Gautham Reddy are conducting a study to evaluate the safety and effectiveness of two study drugs in treating hepatic encephalopathy. One of the drugs used in this study is considered experimental which means it has not been approved by the Food and Drug Administration (FDA). The other has been approved by the FDA for the treatment of hepatic encephalopathy.

If you meet the conditions required to participate in this study and decide to participate, you will be randomly (like the flip of a coin) be assigned to one of the two drugs in this study. Once it is determined which drug you will be taking, you will be given a four-week supply of the study drug and asked to come to the clinic for regular visits. During the first week of the study, you will have three study visits at Days 0, 3, and 7. During the second week of this study, you will have two study visits at Days 10 and 14. For the remaining three weeks of the study (Weeks 3, 4, and 5), you will be required to visit the clinic only one time each week. Some of the tests and procedures involved in this study include: physical exams, blood draws and pregnancy tests.

You may not benefit directly from this research. During the course of this study, the drug you are receiving may or may not be effective in treating your hepatic encephalopathy.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must have a person (spouse, friend, or relative) willing to accompany you to the study visits
• Must meet study criteria as evaluated by Dr. Reddy

Study Director: Dr. Gautham Reddy
Department: Medicine, Section of Gastroenterology, Center for Liver Diseases

For more information contact:
Katie Wherity, RN
(773) 702-4477

IRB: #15564A