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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Interferons; Ribavirin

Criteria

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