Chronic active hepatitis C never treated previously with anti-viral terapie MedDRA version: 14.0 Level: PT Classification code 10019755 Term: Hepatitis chronic active System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: Victrelis
Pharmaceutical Form: Capsule
Other descriptive name: Boceprevir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: PEGINTRON*SC
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Male or female, aged from 18 to 70 years old, inclusive. · Willing and able to provide written informed consent · Chronic HCV infection for at least 6 month prior to baseline (Day 1) in subjects currently positive for HCV-RNA and anti-HCV antibody documented by: · A positive anti-HCV antibody test, positive HCV-RNA assay, or HCV genotype test at least 6 month prior to baseline (Day 1) or · Subjects must have liver biopsy results (performed no more than two years prior the screening) indicating the absence of cirrhosis · HCV infection limited to genotype 1 · Detectable plasma HCV-RNA at screening · BMI between 18 and 36 Kg/m2 · Eligible subjects must also be HCV treatment-naïve, defined as no prior exposure to PEG-INF and ribavirin, and must be eligible to standard of care therapy with PEG/RBV · Subjects must have the following laboratory parameters at screening: ALT and AST £ 5 x upper limit of normal range (ULN) Hemoglobin (Hb) ³ 12 g/dl WBC ³ 2.500 cells/mL with absolute neutrofil count ³ 1500 cells/mL If a woman of childbearing potential, must have negative serum b-human chorionic gonadotropin (b-HCG) pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment A female subjects of childbearing potential and nonvasectomized male subjects with a female partners of childbearing potential must agree that they and their partner will use effective contraception (two separate forms of contraception simultaneously, one of which must be a male condom with spermicide) from screening throughout the duration of study treatment and for at least 7 months Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: · Pregnant women or women who may wish to become pregnant during the course of the study · Male with a female who is pregnant or is planning to become pregnant within seven month the study of anticipated last dose of ribavirin · Evidence of infection or co-infection with a no-genotype 1 HCV-strain · History of hemoglobinopathy · History of sarcoidosis · History of invasive malignancy diagnosed or treated within 5 years. · Untreated or significant psychiatric illnesses including severe depression, schizophrenia, psychosis, history of a suicide attempt · Co-infection with HBV or HIV · Chronic use of systemic immunosuppressive agents · Presence of autoimmune disorders; subjects with treated hypothyroidism with normal TSH may be enrolled · History of significant cardiac disease · Clinical evidence of chronic pulmonary disease · Known cirrhosis · History of solid organ transplantation · Suspicion of hepatocellular carcinoma · Chronic liver disease of a non-HCV etiology · Ongoin alcohol abuse · History of clinical relevant drug abuse · Positive urine screen for cocaine, opiate etc, or methadone use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to define the effect of anti-viral therapy with boceprevir on protective adaptive immune responses in patients with chronic hepatitis C by assessing: - whether viral suppression and decline of antigenemia induced by antiviral therapy are associated with a progressive restoration of HCV-specific antiviral T cell functions; - to what extent functional reconstitution results in maturation of fully differentiated effector and memory T cells, as observed after spontaneous control of HCV infection; - whether a hierarchical restoration of different T cell functions occurs over time upon viral control in individual patients.;Secondary Objective: To assess whether the efficiency of pre-treatment antiviral T cell responses can predict response to boceprevir treatment;Primary end point(s): Generation of novel information about the mechanisms of action through which the new anti-virals can inhibit HCV replication;Timepoint(s) of evaluation of this end point: Two years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Generation of novel information about the mechanisms of protective T cell mempry maturation after long-term exposure to high antigen concentrations;;Timepoint(s) of evaluation of this end point: TWO YEARS | — |
Countries
Italy
Contacts
Public ContactSegreteria Tecnico-Scientifica
Comitato Etico Unico per la Provincia di Parma
Outcome results
None listed