A Phase 2, Randomized, Double-Blind, Comparator-Controlled, 12-week Trial of IMO-2125 plus Ribavirin in Patients Infected with Hepatitis C Virus who were Nonresponders to Pegylated-Interferon plus Ribaviri
- Conditions
- 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: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2010-021963-34-HU
- Lead Sponsor
- Idera Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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 <10x the upper limit of normal (ULN)
– total bilirubin <1.5x ULN;
– albumin >3.0 g/dL
– international normalized ratio (INR) <1.5;
- Has documented absence of liver cirrhosis either by liver biopsy within the past 36 months or by FibroScanTM within the past 18 months;
- Has documented absence of a liver mass consistent with malignancy by an imaging study (i.e., ultrasound, radionucleotide liver scan, abdominal CT or MRI scan) within the past 6 months;
- Is age 18 to 65 years, inclusive;
- Completes the informed consent procedure (see Section 15.3), including signing and dating the informed consent form;
- Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment;
- 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) from Screening through the treatment period and for six (6) months after the last dose of ribavirin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Has known hypersensitivity to any oligodeoxynucleotide;
- Is nursing;
- Has body weight <50 kg;
- Has BMI >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) <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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method