Experimental Drug Study for Chronic Hepatitis C (HCV)

Study Summary

The University of Chicago and Dr. Donald Jensen are conducting a study to compare the safety and effectiveness of 12 weeks of a higher dose Pegasys followed by 36 weeks of the approved weekly dose of Pegasys with that of the regimen currently approved by the FDA for people who are infected with genotype 1 HCV. Giving Pegasys at a higher dose is considered experimental and has not been approved by the Food and Drug Administration (FDA).

Another purpose of this study is to compare the safety and effectiveness of higher doses of Copegus with that of the regimen currently approved by the FDA for people who are infected with genotype 1 HCV. Giving Copegus at a higher dose is considered experimental and has not been approved by the Food and Drug Administration (FDA).

You are being asked to participate in a study in which neither you nor your doctor will know which Pegasys dose you will be taking for 12 weeks. Additionally, neither you nor your doctor will know which dose of Copegus you will be taking for the entire study. When the study is complete at all participating research centers, your doctor will be told what doses of Pegasys and Copegus you were taking.

If you meet the conditions required to participate in this study and decide to participate, you will be assigned to one of four groups by a process called randomization (similar to being assigned by the flip of a coin).

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

Your hepatitis C may stabilize or improve while taking Pegasys and Copegus. However, we cannot and do not guarantee or promise that you will receive any benefits from this study. This study may not cure your hepatitis and that your condition may remain unchanged or could even worsen during your participation in the study.

It is possible that you may receive no benefit from being in this study, but you may be helping future patients by providing important information about the treatment of chronic hepatitis C genotype 1 virus infection.

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. Jensen

Study Director: Dr. Donald Jensen
Department: Medicine, Section of Gastroenterology

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

Heather Jernstad RN
(773) 702-2788

IRB: #15016A