Clinical trial NCT01055821 (phase 2, status: completed)
Conditions: chronic hepatitis c infection
ICD codes: B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2
Drugs: pegylated interferon and ribavirin
SMILES: NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  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 < F4 (METAVIR); in case of no available results, a liver biopsy
             will be performed prior to treatment;

          -  All laboratory parameters must be grade 0 or 1 (as per CTCAE criteria) except for
             alanine amino-transferase (ALT), aspartate amino-transferase (AST), gamma glutamyl
             transferase (GGT) and alkaline phosphatase (ALP) for which a grade 2 will be allowed
             if stated non clinically significant;

          -  No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg
             positive);

          -  No intravenous (IV) drug or alcohol abuse;

          -  Serum thyroid stimulating hormone (TSH) levels within normal ranges, regardless of
             treatment with L-thyroxin;

          -  Normal electrocardiogram (ECG);

          -  Normal retinal examination (eye fundus) within last 12 months for diabetic patients or
             patients suffering from high blood pressure;

          -  Negative pregnancy test in women of childbearing potential (a woman who is two years
             post-menopausal or surgically sterile is not considered to be of childbearing
             potential);

          -  Female patients and female partners of male patients (if childbearing potency) must
             agree to use two effective methods of birth control during the study and for 6 months
             after the end of treatment. One of the methods needs to be a 'barrier' method (condom
             or diaphragm);

        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 arterial 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 eggs;

          -  Women who are breastfeeding;