MedTrace Logo

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

NCT00990938 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-02-15

Study results available
· View outcomes & findings →

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).

Conditions

  • Hepatitis C, Treatment Naïve, Genotype 1 Patients

Interventions

DRUG

IMO-2125

IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system.

DRUG

Saline

Subcutaneous injection once per week for four weeks

Sponsors & Collaborators

  • Idera Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-05-31
Completion
2011-01-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990938 on ClinicalTrials.gov