Experimental Drug Study for Chronic Hepatitis C (HCV)
Study Summary
The University of Chicago and Dr. Nancy Reau are conducting a study to determine if alb-IFN is effective and safe when given in combination with ribavirin, an FDA approved medication. Another purpose is to evaluate how safe and effective alb-IFN plus ribavirin is compared to peginterferon alfa-2a (another alfa interferon product also known as Pegasys® in combination with ribavirin. The combination of Pegasys and ribavirin is approved by the FDA for the treatment of patients with hepatitis C.
You will be randomly (by chance--like a flip of a coin) assigned to one of three study drug groups. You will have equal chance of being placed in one of these three groups. Two of these groups will receive alb-IFN with ribavirin and one 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, liver biopsy, chest x-ray, pregnancy testing, laboratory tests requiring blood draws, completion of questionnaires and ECGs (the electrical impulses of the heart will be measured).
Benefits
You may or may not experience a reduction in the amount of hepatitis C virus in your body as a result of being on this study. It is not yet known if alb-IFN is effective in treating hepatitis C. 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 treatment of future subjects with conditions similar to 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. Reau
Study Director: Dr. Nancy Reau
Department: Medicine, Section of Gastroenterology
For more information contact:
Katie Wherity, RN
(773) 702-4477
Heather Jernstad, RN
(773) 702-2788
IRB: #15225B
