This is a Phase 2, randomized, double-blind, comparator-controlled study of IMO-2125 in hepatitis C-infected patients who were previously nonresponders to standard treatment (pegylated-interferon plus ribavirin) – that is, were treated at least 12 weeks and never achieved an undetectable viral load during or at the end of treatment. The population under study is nonresponder patients with chronic hepatitis C virus (HCV) infection. MedDRA version: 12.1 Level: LLT Classification code 10008912 Ter
Conditions
Interventions
Product Name: IMO-2125
Product Code: IMO-2125
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: IMO-2125
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Idera Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To qualify for enrollment, a patient must meet all of the following criteria: - Has HCV plasma viral load >10,000 IU/mL; - Is infected only with HCV genotype 1; - Has previously received at least 12 weeks of treatment with pegylated-interferon plus ribavirin and failed to achieve an undetectable viral load at any time during or at the end of treatment; - Has not previously received more than four (4) weeks of an investigational treatment for HCV and must not have received any such treatment in the past three (3) months; - Has no other cause of significant liver disease, including, but not limited to, hepatitis B, drug- or alcohol related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. - Has adequate liver function as documented by: – alanine aminotransferase (ALT) value 3.0 g/dL – international normalized ratio (INR) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Has known hypersensitivity to any oligodeoxynucleotide; - Is nursing; - Has body weight 34.9 kg/m2; - Regularly consumes >3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day; - Has used any cocaine or heroin products within the past 12 months; - Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2); - Has a positive test for hepatitis B surface antigen (HbsAg); - Has a hemoglobin (Hb) 1.1x ULN; - Has a history of autoimmune or antibody-mediated diseases, including, but not limited to, the following: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren’s syndrome with demonstrable antibodies, and autoimmune thrombocytopenia; - Has a history of allogeneic organ transplant (including bone marrow or stem cells); - Has active depression uncontrolled by treatment, a history of attempting suicide, or a history of being hospitalized in the past 10 years for psychiatric illness (e.g., depression, schizophrenia, psychosis) ; - Has other significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (unstable angina, myocardial infarction, congestive heart failure, or ventricular arrhythmia); cancer; uncontrolled seizure disorder; encephalopathy; esophageal bleeding; ascites; chronic infection other than HCV (e.g., tuberculosis); uncontrolled diabetes; - Has received within the past three months or is expected to receive during the study period any of the following treatments: – Immunosuppressive drugs, including, but not limited to, cytotoxic agents, monoclonal antibodies (against cytokines or cell-associated antigens), calcineurin inhibitors (and related agents), systemic (oral or intravenous) corticosteroids. – Hematopoietic stimulating agents, including, but not limited to, erythropoietin, G-CSF, GM-CSF. – Warfarin >1 mg/day – Another investigational drug. - Has planned, or is expected to require, during the study period, any surgery requiring general anesthesia; - Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient’s successful completion of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of different regimens of IMO-2125 in combination with ribavirin compared to PegasysTM plus ribavirin administered for 12 weeks to patients with chronic HCV infection who were nonresponders to prior treatment with pegylated-interferon plus ribavirin.;Secondary Objective: To assess the effect of 12-week treatment with IMO-2125 plus ribavirin on viral load in patients with chronic HCV infection who were nonresponders to prior treatment with peg-IFN plus ribavirin.;Primary end point(s): The endpoints defined after 12 weeks of treatment are virologic response (VR; at least a 2 log10 decrease in HCV RNA viral load compared with pretreatment) and early virologic response (EVR; undetectable HCV RNA). The effect of treatment on HCV viral load will be assessed for the Per Protocol population by comparing the proportion of subjects achieving the following end points in each IMO-2125 arm with that for peg-rIFN arm: – virologic response (VR): HCV RNA viral load at EOT at least 2 log10 less than the pretreatment baseline; – early virologic response (EVR): undetectable HCV RNA viral load at EOT. | — |
Countries
Bulgaria, Hungary
Outcome results
None listed