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

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01349465

Run by

Janssen R&D Ireland

People needed

249

Starts

2011-07-04

Expected to finish

2016-01-05

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Bakersfield, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — San Antonio, Texas, United States
• Study site — Antwerp, Belgium
• Study site — Bruges, Belgium
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Montreal, Canada
• Study site — Créteil, France
• Study site — Grenoble, France
• Study site — Lyon, France

Full record on ClinicalTrials.gov

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