Chronic active hepatitis C never treated previously with anti-HCV therapies MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: INCIVO
Pharmaceutical Form: Tablet
Current Sponsor code: TELAPREVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 375-
Trade Name: REBETOL*140CPS 200
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Be a man or woman between 18 and 70 years of age • Sign the informed consent document indicating that they understand the purpose of and procedures required for the immunological study • Have evidence of HCV infection with genotype 1 (molecular assay) diagnosed at least 6 months before the baseline • Have documented mild or moderate liver fibrosis (Metavir F0-F2 or Ishak 0-2) assessed by liver biopsy in the past 12 months • Have a favorable IL28B genotype (CC) • BMI =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Pregnant woman or woman who wants to become pregnant during the course of the study • Infected or coinfected with HCV of a genotype other than genotype 1 • CT or TT genotype of IL28, presence of severe fibrosis at the liver biopsy (Metavir > 2 o Ishak > 2) • History of hemoglobinopathy, sarcoidosis, invasive neoplasia diagnosed or treated in the previous 5 years • History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease • Co-infection with HBV or HIV • Chronic use of systemic immunepressive agents • Presence of autoimmune disorders; patients with hypothyroidism and normal TSH can be enrolled • History of severe heart or chronic pulmonary diseases • History of solid organ transplantation • Suspected hepatocellular carcinoma • Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess whether pre-treatment T cell responses can predict the final outcome of therapy;Primary end point(s): Generation of novel information about the immune mechanisms of anti-viral control in HCV infection in the perspective of novel immune therapies;Timepoint(s) of evaluation of this end point: Two years;Main Objective: To characterize the effect of telaprevir therapy on adaptive immune responses in patients with chronic hepatitis C assessing: - whether viral suppression and decline of antigenemia induced by antiviral therapy are associated with a progressive restoration of 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; - whether the emergence of HCV mutants resistant to therapy can impair anti-viral T cell responses; - whether different levels of efficiency of pre-treatment antiviral T cell responses can predict response to treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Generation of novel information about the mechanisms of action through which telaprevir can inhibit HCV replication;Timepoint(s) of evaluation of this end point: Two years (24 months) | — |
Countries
Italy
Contacts
Public ContactSegreteria Comitato Etico
Azienda Ospedaliero-Universitaria di Parma
Outcome results
None listed