Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Primary Purpose
Hepatitis C, Treatment Naïve, Genotype 1 Patients
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
IMO-2125
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Treatment Naïve, Genotype 1 Patients
Eligibility Criteria
Inclusion Criteria:
- Documented genotype 1
- HCV-positive with documented detectable plasma viral concentration > 10,000 IU/mL
Exclusion Criteria:
- Positive test for HIV or HbsAg
- Inadequate bone marrow, liver, and renal function
- Treatment with any IFN-based or other experimental or antiviral therapies - prior or current
- Other significant medical disease
- Concurrent or planned treatment during the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline
IMO-2125
Arm Description
If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks
If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks
Outcomes
Primary Outcome Measures
At Least 1 TEAE
The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category.
Secondary Outcome Measures
Full Information
NCT ID
NCT00990938
First Posted
October 6, 2009
Last Updated
October 1, 2018
Sponsor
Idera Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00990938
Brief Title
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Treatment Naïve, Genotype 1 Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks
Arm Title
IMO-2125
Arm Type
Experimental
Arm Description
If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
IMO-2125
Intervention Description
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 Type
Drug
Intervention Name(s)
Saline
Intervention Description
Subcutaneous injection once per week for four weeks
Primary Outcome Measure Information:
Title
At Least 1 TEAE
Description
The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category.
Time Frame
From first dose of study treatment to day 59 (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented genotype 1
HCV-positive with documented detectable plasma viral concentration > 10,000 IU/mL
Exclusion Criteria:
Positive test for HIV or HbsAg
Inadequate bone marrow, liver, and renal function
Treatment with any IFN-based or other experimental or antiviral therapies - prior or current
Other significant medical disease
Concurrent or planned treatment during the study
Facility Information:
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.iderapharma.com
Description
Related Info
Learn more about this trial
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
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