Study about human defence for chronic hepatitis C in patients who will be treated with telaprevir with peginterferon-alfa and ribaviri

• Conditions: Chronic hepatitis C; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005636-26-NL
• Lead Sponsor: Foundation for Liver Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-23
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1.To determine the gene expression profiles of liver immune cells before, during and after treatment<br>2.To determine the effect of telaprevir on the activation of the type I IFN signalling pathway<br>3.To determine the phenotype and function of blood leukocytes during treatment; with focus on T cells, NK cells and monocytes.<br>4.To determine the difference in changes in intracellular processes in immune cells between responders and non-responders upon telaprevir treatment.<br>;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 Outcome Measures

Name	Time	Method
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