The primary objective for this study is to compare the effectiveness of 9mg Interferon Alfacon-1 administered under the skin, three times per week for 72-weeks, or once daily for 48-weeks in subjects with chronic HCV infection (previously untreated with interferon). Effectiveness is defined by undetectable serum HCV RNA levels 24-weeks following the last injection. Secondary objectives are to evaluate the safety and tolerability of 9mg Interferon Alfacon-1. Interferons are a group of small proteins which are made and released by cells in the body in response to activation of the immune system. Interferon Alfacon-1 is a man-made interferon. It is structurally similar to other natural interferons. It is produced by bacteria genetically altered for this specific purpose. This research study will look at the drug to determine if giving the drug more frequently over a longer period of time will help a higher proportion of study subjects. Ten to fifteen hospitals in North America will participate in the study and 30-35 hospitals in Europe.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000051-39
Application #
6414397
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Colorado Denver
Department
Type
DUNS #
065391526
City
Aurora
State
CO
Country
United States
Zip Code
80045
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