Overview

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.
Phase:
Phase 3
Details
Lead Sponsor:
Janssen R&D Ireland
Treatments:
Peginterferon alfa-2a
Ribavirin
Simeprevir