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Effect of Teleprevir in Triple Therapy on Intrahepatic Immunological Mechanisms

NCT01641094 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2015-03-11

No results posted yet for this study

Summary

Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million people. The previous standard of care therapy of chronic HCV patients consists of pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has previously proven to offer therapeutic options to previous non-responders to the standard of care. Although, not all chronic HCV patients benefit from telaprevir and it is still not known why certain patients are also non-responsive to this triple therapy. In this study we try to understand why certain patients are also non-responsive to telaprevir, how triple therapy modulates the responsiveness to IFN-α and what the immunological consequences are of treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of HCV-RNA levels.

Conditions

  • Chronic Hepatitis C

Sponsors & Collaborators

  • Janssen-Cilag B.V.

    collaborator INDUSTRY

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • A. Boonstra, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01641094 on ClinicalTrials.gov