Conditions: Hepatitis C, Treatment Naïve, Genotype 1 Patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief 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).

Detailed description:
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms, ribavirin will be dosed based on patient weight.

Approximately 50 patients will be enrolled in France and Russia. Patients will provide informed consent prior to any screening procedures being performed. Screening will occur within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period.

Patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.

Arms:
arm 1: If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks arm 2: If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks

Interventions: intervention 1: IMO-2125 intervention 2: Saline
Intervention descriptions: intervention 1: 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. intervention 2: Subcutaneous injection once per week for four weeks

Protocol document: