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 Ribavirin

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-021963-34-BG
• Date of registration: 08/11/2010
• Prospective Registration: Yes
• Primary sponsor: Idera Pharmaceuticals, Inc.
• Public title: 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 Ribavirin
• Scientific title: 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 Ribavirin
• Date of first enrolment: 23/12/2010
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021963-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Bulgaria, Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
To be eligible for this study, a patient must meet all of the following inclusion criteria:
- Is age 18 to 65 years, inclusive;
- Completes the informed consent , 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 start of treatment;
- Female subjects of childbearing potential 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) yes
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

Exclusion criteria:
A patient who meets any of the following exclusion criteria will not be enrolled in the study:
- Has known hypersensitivity to any oligodeoxynucleotide;
- Is nursing (females);
- Has body weight <50 kg;
- Has BMI >34.9 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 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 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.34
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Genotype-1 Chronic Hepatitis C Virus (HCV) Infection
MedDRA version: 12.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C

Intervention(s)

Product Name: IMO-2125
Product Code: IMO-2125
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: NA
Current Sponsor code: IMO-2125
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
CAS Number: 198153-51-4
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Copegus
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

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 nonresponder 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)

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 nonresponder patients with chronic HCV infection

Secondary ID(s)

2125-202

2010-021963-34-HU