Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Hepatitis C, Treatment Naïve, Genotype 1 Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Safety and tolerability of 3 different dosages of IMO-2125 in combination with standard ribavirin compared to placebo and ribavirin. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Assess rapid viral response (RVR) rate, defined as undetectable HCV-RNA at week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Assess the effects of 3 different dosages of IMO-2125 in combination with standard ribavirin on viral load [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Characterize the pharmacodynamics in combination with ribavirin in HCV-infected patients [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Describe the viral kinetics per individual patient [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Saline
If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks
Subcutaneous injection once per week for four weeks
If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990938
|Rennes, France, 35000|