Approximately 100 treatment-naïve adults with chronic hepatitis C genotype 1, who meet eligibility criteria, will be enrolled at approximately 35 study sites in Europe and the United States (U.S.). MedDRA version: 9.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV)
Conditions
Interventions
Product Name: Locteron
Product Code: BLX-883
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: interferon alfa-2b
Current Sponsor code: BLX-883
Other descripti
Sponsors
Biolex Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Willing and able to provide written informed consent • Male and female subjects 18 through 69 years of age, inclusive • Chronic hepatitis C genotype 1 • HCV ribonucleic acid (RNA) level > 10,000 IU/mL (by RT-PCR) at screening • Creatine clearance >= 50 mL/min • Neutrophil count > 1500 cells/mm3 • Platelet count > 90,000/mm3 • Hemoglobin > 12 g/dL for females and > 13 g/dL for males • Female subjects of child-bearing potential agreeing to use dual methods for contraception (oral or parenteral contraceptive drugs + barrier method) for the duration of the study and up to 24 weeks after stopping study drug • Male subjects with female sexual partners agreeing to use effective birth control methods for the total duration of the study and up to 28 weeks after stopping study drug • Negative serum pregnancy test for women of child-bearing potential at screening and confirmed by negative urine pregnancy test within the 24-hour period prior to the first dose of study drug • Compensated liver disease defined as INR 3.0 g/dL 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
Exclusion criteria: • Prior antiviral treatment for hepatitis C (defined as more than one dose of interferon based therapy and any administration of a targeted antiviral therapy) • Co-infection with HIV or hepatitis B virus (HBsAg positive), acute hepatitis A (HAV IgM positive) • Subjects with a body mass index (BMI) above 32 kg/m2 • Current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage) • Evidence of HCC; for example, alpha-fetoprotein > 50 ng/mL or by any other standard of care measure • Uncontrolled diabetes mellitus as evidenced by HbA1C = 8.5% at screening • Known hypersensitivity to interferon alfa or ribavirin, or with any other contraindications to these medications, e.g. after use of these agents for non-hepatitis C disorders • Chronic liver disease other than HCV not limited to HBV, hemochromatosis, auto-immune hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease) • Clinically significant hemoglobinopathy such as thalassemia major and sickle cell anemia • History of moderate, severe or uncontrolled psychiatric disease including depression and prior suicide attempts • History of immune-mediated disease (e.g., inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, moderate to severe psoriasis, rheumatoid arthritis, antinuclear antibody (ANA) titer >= 1:640 at screening) • Significant renal or neurological disease • Severe degree (> GOLD stage III) of chronic pulmonary disease (COPD) or active, severe asthma • Subjects with severe cardiac disease (e.g., heart failure, recent [i.e., within 6 months prior to first dosing] myocardial infarction, angina, serious arrhythmias, including prolonged QTc [> 450 mSec], uncontrolled hypertension) • History of significant central nervous system (including CNS trauma) or seizure disorders • Cancer within the last 5 years, or previous cancer with a high risk of recurrence, including metastatic breast cancer; non-melanoma skin cancer is not an exclusion criterion • History of solid organ or bone marrow transplantation • Clinical or laboratory evidence of uncontrolled thyroid disease, e.g., by thyroid stimulating hormone (TSH) level > 1.2 x upper limit of normal • Clinically significant retinopathy; this needs to have been excluded by an eye exam performed by an ophthalmologist within the last 6 months prior to screening for subjects with hypertension or diabetes mellitus • Drug abuse or alcohol consumption within the last 6 months which, in the opinion of the investigator, may affect study participation or outcome. Subjects in a supervised methadone treatment program on a stable regimen for > 6 months may be considered • Taken any experimental agent within 12 weeks prior to screening • More than 30 days of systemic immunosuppressive medication to include steroids in doses equivalent to or greater than 10 mg prednisone per day within 30 days prior to screening (inhaled corticosteroids are allowed) • Nursing mother or male partner of pregnant female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin: the virologic response to 3 dose levels of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly. ;Secondary Objective: To assess the safety, tolerability and immunogenicity of 3 dose levels of Locteron™ compared to that of PEG-Intron™ including the intensity and duration of flu-like symptoms as measured by ePRO and by clinic visit assessments the rates of dose reductions and of study drug discontinuations for tolerability reasons of 3 dose levels of Locteron™ compared to that of PEG-Intron™ the pharmacokinetics profiles of 3 dose levels of Locteron™and of PEG-Intron™ the impact on general health-related quality of life, as measured by SF-36 and HQLQ of 3 dose levels of Locteron™ and of PEG-Intron™ the impact on the onset of depression and depressive symptoms, as measured by the Becks Depression Inventory of 3 dose levels of Locteron™ and of PEG-Intron™ the impact on days missed from work during treatment with one of 3 dose levels of Locteron™ and of PEG-Intron™ the incidence of binding and neutralizing antibodies to interferon alpha 2b in the 3 dose levels of Locteron™ and of PEG-Intron™. ;Primary end point(s): The primary efficacy endpoint for this study is the proportion of subjects exhibiting an early virologic response (EVR) defined as at least a 2 log drop in HCV RNA from baseline after 12 weeks of treatment. Secondary efficacy endpoints are as follows: • The proportion of subject in each treatment arm that achieve sustained virologic response (SVR), defined as exhibiting undetectable (< 10 IU/mL) HCV RNA at the end of the follow-up period (24 weeks after the end of therapy) • The proportions of subjects in each treatment arm that achieve rapid virologic response (RVR), defined as exhibiting undetectable HCV RNA after 4 weeks of therapy • The proportion of subjects in each treatment arm that achieve | — |
Countries
Bulgaria, France, Germany
Outcome results
None listed