Phase 1
Completed N=58
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Source: ClinicalTrials.gov NCT00728936 ↗Enrolled (actual)
58
Serious AEs
1.7%
Results posted
Feb 2019
Primary outcomePrimary: Evaluation of Safety. — 6; 8; 9; 8 Participants
Summary
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Safety. |
6; 8; 9; 8; 8; 8 | — |
Eligibility Criteria
Inclusion Criteria
- HCV-positive
- Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
Exclusion Criteria
- Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
- Inadequate bone marrow, liver, and renal function
- Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
- Other significant medical diseases
- Known alcohol or drug abuse within the past 12 months
Data sourced from ClinicalTrials.gov (NCT00728936). 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.