NCT01641094

Effect of Teleprevir in Triple Therapy on Intrahepatic Immunological Mechanisms

Effect of Telaprevir in Triple Therapy on Intrahepatic Immunological Mechanisms.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2012-07-16
• Last updated: 2015-03-11

Locations

2 sites across 1 country: Netherlands