Experimental Drug Study for Subjects with Genotype 1 Hepatitis C Virus (HCV)

The University of Chicago and Dr. Jensen are conducting a study to see whether an experimental drug useful for chronic genotype 1 Hepatitis C when taken in combination with the standard of care drugs for HCV, Pegasys® and Copegus® (ribavirin).

This experimental drug is an HCV protease inhibitor. This means that it interferes with the ability of the HCV virus to make copies of itself. An experimental drug is one that is not approved by the US Food and Drug Administration (FDA). Pegasys® and Copegus® are approved by the FDA for the treatment of chronic HCV infection.

After you are screened for study participation, you will be assigned by chance (like the flip of a coin) to one of five study groups. Depending on the group you are assigned to, you will receive different doses of the experimental drug or a placebo (a sugar pill with no active drug).

Subjects in all five groups will receive the standard of care drugs. Neither you nor your study doctor will know which study group you are assigned to.

As part of the study, you may undergo tests/procedures such as physical exams, ECGs, liver biopsies, eye exams, urine tests, blood tests, and pregnancy tests free of charge.

You may participate in this study for up to 72 weeks with up to 20 visits to the clinic at the Duchossois Center for Advanced Medicine. Participants will receive $33 for each visit they complete as well as parking passes for clinic visits.

There is no guarantee that you will receive any benefit from taking part in this study. Possible benefits include your condition remaining the same or improving.

Participation Details:

• Must be between 18 and 70 years of age
• Must have been diagnosed with genotype 1 HCV
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Jensen

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

For more information, contact:

Monique Williams, RN
Audrey Silver, RN
1-877-UC-LIVER

IRB:#16924B