12-week Trial of IMO-2125 plus Ribavirin in Patients Infected with Hepatitis C Virus who have never before received any treatment for this infectio
- Conditions
- Treatment-Naive Patients Infected with Hepatitis C Virus Genotype 1.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000091-33-HU
- Lead Sponsor
- Idera Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
• Is age 18 to 65 years, inclusive;
• Completes the informed consent procedure (see Section 15.3), 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 dosing;
• Female subjects of childbearing potential (see Section 8.3.1) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.3.1) from Screening through six (6) months after the last study dose of ribavirin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Has known hypersensitivity to any oligonucleotide;
• Is nursing (females);
• Has body weight <50 kg;
• Has BMI =35 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 creatinine clearance (Clcr) <70 mL/min calculated using the Cockroft-Gault equation
• 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.
– 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 treatment-naïve patients with chronic HCV infection;Secondary Objective: 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 treatment-naïve patients with chronic HCV infection;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).;Timepoint(s) of evaluation of this end point: 4 weeks, 12 weeks
- Secondary Outcome Measures
Name Time Method