Experimental Study for Subjects with Acute on Chronic Hepatitis (AOCH)

The University of Chicago and Dr. Te are conducting a study to determine the safety and the effectiveness (how well the system works) of a liver assist system. It is designed to provide liver support continuously to subjects with liver failure. The system may potentially treat the sudden worsening of people with liver disease. However, it will not treat liver failure.

This system is a dialysis type pump system containing cartridges with filters in them. These filters are made up of hollow tubes that contain human liver cells that have been grown in a laboratory. This system is experimental, which means that it has not been approved by the U.S. Food and Drug Administration (FDA), and it is not an approved for any disease or medical condition

After being screened for study participation, subjects will be randomly assigned (like the flip of a coin) to receive either standard medical therapy for liver failure plus the experimental system, or standard medical therapy alone. He/she may participate in this study for up to 93 days.

As part of the study, subjects may undergo the following tests (additional test/procedures may be required): physical exams, blood tests, urine tests and pregnancy tests.

There is no guarantee that subjects will receive any benefit from taking part in this study.

Participation Details:

• Must be between 18 and 65 years of age
• Must have acute on chronic hepatitis
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Te

Study Director: Dr. Helen Te, MD
Department: Medicine, Section of Gastroenterology

For more information contact:
Sara Rosenkoetter, RN
(773) 834-9796

IRB: #09-154-B