Phase 1
Completed N=63
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Hepatitis C, Treatment Naïve, Genotype 1 Patients
Source: ClinicalTrials.gov NCT00990938 ↗
Enrolled (actual)
63
Serious AEs
39.7%
Results posted
Feb 2019
Primary outcomePrimary: At Least 1 TEAE — 2; 12; 12; 12 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY At Least 1 TEAE |
2; 12; 12; 12; 12; 12 | — |
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
Data sourced from ClinicalTrials.gov (NCT00990938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.