Treatment of patients with chronic genotype 1 hepatitis C MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: TG4040
Pharmaceutical Form: Solution for injection
Current Sponsor code: TG4040
Other descriptive name: MVA-HCV
Concentration unit: PFU plaque forming unit
Concentration type: equal
Conc
Sponsors
TRANSGENE S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, age =18 to = 70 years; - Chronically infected patients with Hepatitis C virus Genotype 1 (1a or 1b) with detectable viremia (HCV RNA in blood) for more than 6 months and naïve to treatment; - Patients must have compensated liver disease, with no history of ascites, jaundice, hepatic encephalopathy or bleeding from esophageal or gastric varices requiring beta-blockers; - No histological evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 24 months prior to baseline; or on a FibroScan® performed within 6 months prior to treatment which indicates the absence of liver cirrhosis, i.e., stage =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Prior treatment for hepatitis C; - Malignancy within the last 5 years; except for patients with history of squamous cell skin cancer or basal cell skin cancer who will be enrolled, unless patients have a history of skin cancer at the vaccination site; - Diagnosed or suspected hepatocellular carcinoma; - History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Patients with mild to moderate depression in the past and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator’s opinion, they are suitable for treatment; - Serious, concomitant medical disorder, including active systemic infection and proven or suspected immunosuppressive disorder; - History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogenic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, or autoimmune thrombocytopenia; - Administration of any vaccine or immunoglobulin within 30 days before the first dose of TG4040 /SOC; - Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias); - Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first TG4040/SOC administration; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed; - Any known allergy to interferon (IFN), RBV and/or their excipients; - Any medical contraindications to IFN and/or RBV; - Any known allergy to gentamycin, to bovine serum albumin, to eggs; - Women who are breastfeeding; - Participation in another experimental therapeutic protocol within 6 months prior to baseline and during the study period; - Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study; - Patient unable or unwilling to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of TG4040 combined with SOC (Peg-IFN alfa2a and RBV) in treatment-naïve patients with chronic genotype 1 hepatitis C infection as measured by the proportion of patients who achieve complete early virologic response (cEVR is defined as undetectability of the HCV RNA after 12 weeks of SOC).;Secondary Objective: - The evaluation of the effects of TG4040 alone or combined with SOC on viral load, over time, relative to baseline including but not restricted to RVR, EVR, ETR and SVR. - The evaluation of the safety of TG4040 alone and in combination with SOC. - The determination of the immunogenicity of TG4040 alone and in combination with SOC. - The identification of molecular biomarkers related to TG4040 efficacy in combination with SOC by gene expression profiling. ;Primary end point(s): Efficacy: percentage of patients achieving cEVR, defined as undetectable HCV RNA (less than 10 IU/mL, as measured by the Roche TaqMan(R) assay) 12 weeks after the start of SOC.;Timepoint(s) of evaluation of this end point: 12 weeks of SOC | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: see above in parenthesis;Secondary end point(s): - determine the effects of TG4040 alone and in combination with SOC on viral load, relative to baseline (over time and at specific endpoints, and slope of second phase viral dynamic clearance between week 4 and week 12 of SOC); - evaluate the safety of TG4040 alone and in combination with SOC (during the course of the study); - determine the immunogenicity of TG4040 alone and in combination with SOC (specific timepoints); - identify molecular biomarkers related to TG4040 efficacy in combination with SOC by gene expression profiling (specific timepoints). | — |
Countries
Germany, Israel, Poland, Spain, United States
Outcome results
None listed