Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
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
1 other identifier
interventional
63
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
February 15, 2019
CompletedFebruary 15, 2019
October 1, 2018
8 months
October 6, 2009
November 20, 2017
October 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
At Least 1 TEAE
The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category.
From first dose of study treatment to day 59 (end of study)
Study Arms (2)
Saline
PLACEBO COMPARATORIf randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks
IMO-2125
EXPERIMENTALIf randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Documented genotype 1
- HCV-positive with documented detectable plasma viral concentration \> 10,000 IU/mL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Rennes, 35000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Idera Medical Monitor
- Organization
- Idera Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 7, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2010
Study Completion
January 1, 2011
Last Updated
February 15, 2019
Results First Posted
February 15, 2019
Record last verified: 2018-10