E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Genotype-1 Chronic Hepatitis C Virus (HCV) Infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of different dosages of a 12-week course of IMO-2125 plus ribavirin compared to peg-rIFN plus ribavirin administered to nonresponder patients with chronic HCV infection. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect on HCV viral load of a 12-week treatment with IMO-2125 plus ribavirin compared to peg-rIFN plus ribavirin administered to nonresponder patients with chronic HCV infection |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for this study, a patient must meet all of the following inclusion criteria: - Is age 18 to 65 years, inclusive; - Completes the informed consent , including signing and dating the informed consent form; - Has a qualifying HCV infection as defined above; - Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment; - Female subjects of childbearing potential and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception) from Screening through the treatment period and for six (6) months after the last dose of ribavirin. |
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E.4 | Principal exclusion criteria |
A patient who meets any of the following exclusion criteria will not be enrolled in the study: - Has known hypersensitivity to any oligodeoxynucleotide; - Is nursing (females); - Has body weight <50 kg; - Has BMI >34.9 kg/m2; - Regularly consumes >3 drinks of alcoholic drinks (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) <13 g/dL for males or <12 g/dL for females; - Has an absolute neutrophil count (ANC) < 1,500/mm3; - Has a platelet count < 100,000/mm3; - Has a serum creatinine >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 cell transplant); - 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; 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.34 - 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. |
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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A patient will be considered complete if they meet at least one of the following criteria: - completed the 12-week treatment period including the EOT visit as scheduled; - had treatment discontinued due to an adverse event assessed as probably or possibly related to study treatment (including pre-specified treatment-limiting toxicities); - had treatment discontinued due on-treatment failure |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |