Chronic hepatitis C
Conditions
Interventions
Trade Name: Incivo
Pharmaceutical Form: Tablet
INN or Proposed INN: Telaprevir
CAS Number: 402957-28-2
Current Sponsor code: Telaprevir
Other descriptive name: TELAPREVIR
Concentration unit: mg millig
Sponsors
Foundation for Liver Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients between 18 and 70 years of age, with a chronic hepatitis C – genotype 1 infection. • Patients are naive, non-responders or relapsers to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy. • High viral load (>400,000 IU/ml) • Indication for antiviral therapy of hepatitis C according to current clinical guidelines. • Written informed consent. 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Signs of progressive liver disease, beyond generally accepted criteria for HCV antiviral therapy • History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study • Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV). • Presence of contra-indications for antiviral therapy with telaprevir, peginterferon or ribavirin. • Interfering substance abuse, such as alcohol (indicator: 28 drinks/ week). • Earlier treatment with a protease/polymerase inhibitor or treatment with peginterferon/ ribavirin within 6 months before start of therapy •Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To determine the gene expression profiles of liver immune cells before, during and after treatment 2. To determine the effect of telaprevir on the activation of the type I IFN signalling pathway 3. To determine the phenotype and function of blood leukocytes during treatment; with focus on T cells, NK cells and monocytes. 4. To determine the difference in changes in intracellular processes in immune cells between responders and non-responders upon telaprevir treatment. ;Main Objective: To evaluate in detail the functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-alfa and ribavirin.;Primary end point(s): HCV-RNA negativity by qualitative assay 24 weeks after end of treatment (sustained virological response, SVR);Timepoint(s) of evaluation of this end point: Week 24 follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HCV RNA at weeks 4 and 12;Timepoint(s) of evaluation of this end point: Weeks 4 and 12 during therapy | — |
Countries
Netherlands
Contacts
Public Contactharry Janssen
Foundation of liver research
Outcome results
None listed