Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

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

Details

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

Criteria

Inclusion Criteria:

• HCV-positive

• Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

• Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)

• Inadequate bone marrow, liver, and renal function

• Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days

• Other significant medical diseases

• Known alcohol or drug abuse within the past 12 months