Naïve Hepatitis C
Conditions
Interventions
Product Name: IMO-2125
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade
Sponsors
Idera Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 3.0 g/dL – international normalized ratio (INR) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. •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. •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. •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. | — |
Countries
Hungary
Outcome results
None listed