Treatment-Naive Patients Infected with Hepatitis C Virus Genotype 1.
Conditions
Interventions
Product Name: IMO-2125
Product Code: IMO-2125
Pharmaceutical Form: Powder for solution for injection
CAS Number: IMO-2125
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Idera Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • Has known hypersensitivity to any oligonucleotide; • Is nursing (females); • Has body weight 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hungary, Serbia, Ukraine
Contacts
Public ContactClinical Trials Information
Accelsiors CRO and Consultancy Services
Outcome results
None listed