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-HU
• Date of registration: 08/09/2010
• 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: 03/11/2010
• 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 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

Exclusion criteria:
- 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.


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

Health Condition(s) or Problem(s) studied

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: 12.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C

Intervention(s)

Product Name: IMO-2125
Product Code: IMO-2125
Pharmaceutical Form: Powder for solution for injection
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: Copegus
Pharmaceutical Form: Tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Pegasys 180µg
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

Primary Outcome(s)

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).
The effect of treatment on HCV viral load will be assessed for the Per Protocol population by comparing the proportion of subjects achieving the following end points in each IMO-2125 arm with that for peg-rIFN arm:
– virologic response (VR): HCV RNA viral load at EOT at least 2 log10 less than the pretreatment baseline;
– early virologic response (EVR): undetectable HCV RNA viral load at EOT.

Main Objective: To evaluate the safety and tolerability of different regimens of IMO-2125 in combination with ribavirin compared to PegasysTM plus ribavirin administered for 12 weeks to patients with chronic HCV infection who were nonresponders to prior treatment with pegylated-interferon plus ribavirin.

Secondary Objective: To assess the effect of 12-week treatment with IMO-2125 plus ribavirin on viral load in patients with chronic HCV infection who were nonresponders to prior treatment with peg-IFN plus ribavirin.

Secondary ID(s)

2125-202