CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 63 enrolled
Drug / intervention
IMO-2125 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00990938
NCT00990938Phase 1Completed
CompareCT.gov

A Phase 1, Multi-center, Randomized, Double-Blind, Placebo-controlled, Dose-escalation Safety Assessment Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients

Idera Pharmaceuticals, Inc.·interventional·Posted Oct 7, 2009·Updated Feb 15, 2019

In Brief

A Phase 1 clinical trial evaluating IMO-2125 and Saline for Hepatitis C, Treatment Naïve, Genotype 1 Patients. Completed, enrolled 63 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Treatment Naïve, Genotype 1 Patients
CountriesFrance
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.7 years ago

Interventions

IMO-2125drug

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.

Salinedrug

Subcutaneous injection once per week for four weeks