3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2016-01-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Simeprevir

Criteria

Inclusion Criteria:

• Have previously participated in a Phase IIb or Phase III study

• Must have received at least one dose of TMC435 in that study

• Has completed the last post-therapy follow-up visit of the previous (LPVPS) study

Exclusion Criteria:

• Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device

• Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study