A Multi-center, Randomized, Double-blind, Comparator-controlled, Dose-escalation Safety Assessment Study of Combination Treatment with IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients. - 1IDERA1

• Conditions: aïve Hepatitis C

• Registration Number: EUCTR2009-011099-31-HU
• Lead Sponsor: Idera Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

The disease under study is infection with hepatitis C virus (HCV).
Patients must meet all of the following criteria:
• HCV plasma viral load >10,000 IU/mL;
• HCV genotype 1;
• 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;
• Absence of any prior treatment for HCV, approved or investigational, including, but not limited
to, interferon (in any form), ribavirin, or directed” antiviral therapy;
• Absence of liver cirrhosis documented within the past 18 months by liver biopsy or by
FibroScanTM;
• Absence of liver mass consistent with malignancy

Other inclusion criteria are :
•Understand and sign the written informed consent form;
•Age superior or equal to 18 and = 70 years old;
•Have qualifying HCV infection as defined above;
•Female patients of childbearing potential and males who have partners of childbearing potential must agree to use two (2) forms of effective contraception during the treatment period and for the 6-month period after the last dose of the study drug.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known hypersensitivity to any oligodeoxynucleotide;
•Is nursing;
•Is female of childbearing age and is unwilling or unable to practice approved birth-control methods;
•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;
•Positive pregnancy test (females);
•Positive test for antibody to human immunodeficiency virus (HIV-1 or -2)
•Positive test for hepatitis B surface antigen (HbsAg)
•Inadequate bone marrow function as documented by any of the following:
–white blood cell count < 3,000/mm3
–absolute neutrophil count (ANC) < 1,500/mm3
–platelets < 100,000/mm3
–hemoglobin (Hb) < 11 g/dL;
•Creatinine above 1.1x ULN;
•Pre-existing 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
•History of allogeneic organ transplant
•Other significant medical disease, including, but not limited to, cardiac disease (unstable angina, myocardial infarction within the previous 6 months, congestive heart failure, or ventricular arrhythmia); cancer; uncontrolled seizure disorder; cirrhosis; chronic infection other than viral hepatitis (such as known HIV infection); uncontrolled diabetes (HbA1c > 7.5% at screening); or therapeutic dosing with warfarin > 1 mg/day
•Concurrent or planned treatment with any of the following during the study:
–Bone marrow/stem cell transplantation
–Cytotoxic agents
–Oral or intravenous corticosteroids. Topical and intraarticular corticosteroids are allowed. Patients using inhaled steroids for pre-existing respiratory illnesses may be enrolled with the approval of the medical monitor.
–Another investigational drug
•Any planned surgery that will take place during the study period
•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: Assessment of the safety and tolerability of different dosages of IMO-2125 in combination with standard ribavirin compared to placebo and ribavirin or to Pegasys plus ribavirin.;Secondary Objective: •Assess rapid viral response (RVR) rate, defined as undetectable HCV-RNA at week 4, between different dosages of IMO-2125 in combination with standard ribavirin.<br>•To assess the effects of different dosages of IMO-2125 in combination with standard ribavirin on viral load by determining changes from baseline HCV RNA.<br>•To characterize the pharmacodynamics in combination with ribavirin in HCV-infected patients with respect to a variety of immunological and other biological markers of immune stimulation. <br>•To describe the viral kinetics per individual patient over time. ;Primary end point(s): The primary endpoint is an assessment of safety and tolerability of different dosages of IMO-2125 in combination with standard ribavirin.