Experimental Drug Study for Chronic Hepatitis C (HCV)

Study Summary

The University of Chicago and Dr. Gautham Reddy are conducting a study that will evaluate an experimental drug called Albumin interferon alfa-2b for the experimental treatment of hepatitis C. This drug is considered experimental because it has not been approved by the Food and Drug administration (FDA)

The purpose of this study is to determine if alb-INF is safe and effective when used in combination with another drug called ribavirin. Ribavirin is a medication that has been approved by the FDA for the treatment of hepatitis C, when used in combination with an approved alpha-interferon drug. For this study, we will combine ribavirin with the unapproved interferon, the study drug alb-INF. In order to evaluate the safety and effectiveness of this experimental combination, we will compare it to the commonly used, FDA approved combination of ribavirin and peginterferon alfa-2a (an approved interferon drug also known as Pegasys). Therefore, some people in this study will receive the experimental combination of alb-INF and ribavirin, and others will receive the approved combination of Pegasys and ribavirin.

You will be randomly by chance (like the flip of a coin) assigned to 1 of 3 drug groups. You will have an equal chance of being placed in 1 of these 3 groups. Two of these groups will receive alb-IFN with ribavirin and 1 group will receive Pegasys plus ribavirin.

As part of the study, you will be required to undergo the following tests and procedures during your visit to the study doctor (additional tests/procedures may be required): physical exams, eye exam, laboratory tests requiring blood draws, pregnancy testing, completion of questionnaires, pulmonary function test (PFT), which is a breathing tests that measure the amount of air you have in your lungs and how well you can move that air by forcefully and ECGs (the electrical impulses of the heart will be measured)

Benefits

There may be no direct benefit to you as a result of participating in this study The information gained from this study may help in the care of future patients with conditions such as yours.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must never have received previous treatment for Hepatitis C
• Must meet study medical criteria as evaluated by Dr. Reddy

Study Director: Dr. Gautham Reddy
Department: Medicine, Section of Gastroenterology

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

Heather Jernstad, RN
(773) 702-2788

IRB: #15190B