3-year Follow-up Study in Patients Previously Treated With a TMC435 for the Treatment of Hepatitis C Virus (HCV) Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01349465
First received: April 26, 2011
Last updated: August 29, 2014
Last verified: August 2014

April 26, 2011
August 29, 2014
July 2011
February 2016   (final data collection date for primary outcome measure)
  • 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 HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at the last visit of the previous study [ Time Frame: Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with undetectable HCV RNA (<25 IU/mL undetectable) [ Time Frame: Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01349465 on ClinicalTrials.gov Archive Site
  • 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.
  • Change in sequence of the HCV NS3/4A region in patients with late relapse, i.e. relapse after the last visit of the previous study [ Time Frame: Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study ] [ Designated as safety issue: No ]
  • Development of liver disease progression in patients previously treated with a TMC435-containing regimen [ Time Frame: Starting at screening, and then every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
3-year Follow-up Study in Patients Previously Treated With a TMC435 for the Treatment of Hepatitis C Virus (HCV) Infection
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

The purpose of this study is to investigate TMC435 for the treatment of chronic hepatitis C virus (HCV) infection.

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.

Interventional
Phase 3
Not Provided
Hepatitis C
Drug: No treatment
No treatment was given as this is an observational study.
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.
Intervention: Drug: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
249
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have previously participated in a Phase II or Phase III study
  • Must have received at least one dose of TMC435 in that study
  • Has completed the last patient visit of the previous 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 for hepatitis C virus (HCV) between last visit previous study and this study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany,   Poland,   Russian Federation
 
NCT01349465
CR017365, TMC435HPC3002, 2010-019843-20
No
Janssen R&D Ireland
Janssen R&D Ireland
Not Provided
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
Janssen R&D Ireland
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP