The purpose of this study is to compare the tolerability, safety, and effectiveness associated with continuous subcutaneous infusion of INTRON A (by a pump infusion system manufactured by the research study sponsor, Medtronic, Inc.) compared to the current standard of care, PEGINTRON, among subjects with chronic hepatitis C genotype 1 infection.

Eligibility Criteria

To participate in this study, you must be an adult who meets the following criteria:

• Have had no prior treatment for hepatitis C
• Genotype 1 chronic hepatitis C with detectable HCV RNA
• Screening laboratory values, test, and physical exam within acceptable ranges
• After training, proficiency in the use of the external pump infusion system

Study Requirements

This study compares three different dose levels -- three different “arms” -- of INTRON A to the standard of care “arm” consisting of PEGINTRON.

All subjects in all study arms will also receive ribavirin by mouth at the current standard of care dosing, which depends on weight.

Duration

Participation in this study can last as long as 72 weeks, depending on how the HCV responds to the study drugs. This includes 48 weeks of study drug (INTRON A plus ribavirin or PEGINTRON plus ribavirin) and 24 weeks of follow-up.

For more information, contact April Bingham at 919-681-8852 or 866-704-4673.