Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

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

Details

• Lead Sponsor: Idera Pharmaceuticals, Inc.
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

• Documented genotype 1

• HCV-positive with documented detectable plasma viral concentration > 10,000 IU/mL

Exclusion Criteria:

• Positive test for HIV or HbsAg

• Inadequate bone marrow, liver, and renal function

• Treatment with any IFN-based or other experimental or antiviral therapies - prior or current

• Other significant medical disease

• Concurrent or planned treatment during the study