3-year Follow-up Study in Patients Previously Treated With a TMC435 for the Treatment of Hepatitis C Virus (HCV) Infection
The purpose of this study is to investigate TMC435 for the treatment of chronic hepatitis C virus (HCV) infection.
|Official Title:||A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection|
- Number of patients who achieved sustained virologic response (SVR) at the last visit of previous study [ Time Frame: Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ] [ Designated as safety issue: No ]The SVR is measured by the number of patients with undetectable hepatitis C virus (HCV) RNA(ribonucleic acid) <25 IU/mL undetectable.
- Change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at the last visit of the previous study [ Time Frame: Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ] [ Designated as safety issue: No ]
- Change in sequence of the HCV NS3/4A region in patients with late relapse [ Time Frame: Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ] [ Designated as safety issue: No ]The late relapse is defined as the relapse after the last visit of the previous study.
- Assessment of development of liver disease progression in patients previously treated with a TMC435-containing regimen [ Time Frame: At screening, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ] [ Designated as safety issue: No ]Child-Pugh score to evaluate hepatic disease progression will be conducted at timepoints.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Patients who received TMC435 for HCV infection
Patients who completed Phase IIb or Phase III study in which they received a TMC435-containing regimen for the treatment of HCV infection.
Drug: No treatment
No treatment was given as this is an observational study.
This is a 3-year follow-up study in patients who completed a previous Phase II or III study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each participant will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last planned visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349465
Hide Study Locations
|United States, California|
|Bakersfield, California, United States|
|La Jolla, California, United States|
|Los Angeles, California, United States|
|United States, Florida|
|Jacksonville, Florida, United States|
|Orlando, Florida, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Louisiana|
|New Orleans, Louisiana, United States|
|United States, Minnesota|
|Saint Paul, Minnesota, United States|
|United States, Mississippi|
|Tupelo, Mississippi, United States|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
|United States, Texas|
|San Antonio, Texas, United States|
|Calgary, Alberta, Canada|
|Ottawa, Ontario, Canada|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Nice N/A, France|
|Frankfurt A. M., Germany|
|Moscow, Russian Federation|
|Nizhny Novgorod, Russian Federation|
|Saint-Petersburg, Russian Federation|
|Samara, Russian Federation|
|Smolensk, Russian Federation|
|St Petersburg, Russian Federation|
|Stavropol, Russian Federation|
|Study Director:||Janssen R&D Ireland Clinical Trial||Janssen R&D Ireland|