Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin

Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.

This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.

Inclusion Criteria:

• Chronic Hepatitis C with HCV genotype 1 infection
• Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.

Exclusion Criteria:

• Presence or history of non-HCV chronic liver disease
• Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
• Decompensated liver disease