Experimental Drug Study for Chronic Hepatitis C Virus (HCV)
Study Summary
The University of Chicago and Dr. Jensen are conducting a study to compare the safety of an experimental drug when taken for 48 weeks in combination with Pegasys® and Copegus® to the safety of taking Pegasys and Copegus alone. Pegasys taken with Copegus are approved by the FDA to treat Chronic Hepatitis C (CHC) in the United States. An experimental drug is one that has not been approved by the Food and Drug Administration (FDA).
This study is considered a double blinded randomized study. This means you will be randomized (like a flip of a coin) to one of seven groups. Neither you nor your doctor will know whether you are taking the study drug or placebo (a pill with no active study drug that looks like the study drug or Copegus). Each group will receive a combination of drugs for 48 weeks. Additionally, there is a 24-week follow-up period where you will not be taking any study drugs but will be evaluated on the effects of the study drug.
As part of the study, you may undergo the following tests (additional test/procedures may be required) physical exams, eye exam, liver biopsy, chest X-ray, pregnancy testing, laboratory tests requiring blood draws, urine tests, and ECGs (the electrical activity of your heart will be measured).
Your participation in the study is for two years with up to 23 visits to the clinic.
There may or may not be a direct medical benefit to you as a result of taking part in this study. Information from this study may help in the treatment of hepatitis C. This information will add to the medical knowledge of how to diagnose, monitor, or treat people with hepatitis C in the future.
Participation Details
Initial selection criteria include:
- Must be at least 18 to 65 years of age
- Must have CHC genotype 1 (You will be tested for this at screening.)
- 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
Department: Medicine, Section of Gastroenterology
For more information contact:
Katie Wherity, RN
(773) 702-4477
IRB: #15722A
