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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01349465
First received: April 26, 2011
Last updated: March 10, 2017
Last verified: March 2017
April 26, 2011
March 10, 2017
July 4, 2011
January 5, 2016   (Final data collection date for primary outcome measure)
  • Percentage of Participants Maintaining SVR at the Last Available Visit [ Time Frame: Last Available Visit (Month 36 for subjects completing the study) ]
    The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).
  • Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study [ Time Frame: Baseline and Month 36 ]
    Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
  • Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study [ Time Frame: Baseline and Month 36 ]
    Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
  • Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study [ Time Frame: Baseline and Month 36 ]
    Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01349465 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Late Viral Relapse [ Time Frame: End of study (at month 36) ]
    Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.
  • Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: End of study (at month 36) ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus 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 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.
This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] 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 patients 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 hepatitis C 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 post-therapy follow-up 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Hepatitis C
Drug: No treatment
No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.
  • Group 1: TMC 435 - Patients With SVR at LPVPS
    Patients with sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) [Phase IIb or Phase III] in which they received a TMC435-containing regimen for the treatment of HCV infection.
    Intervention: Drug: No treatment
  • Group 2: TMC 435 - Patients With No SVR at LPVPS
    Patients with no sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) [Phase IIb or Phase III] 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.
 
Completed
249
January 5, 2016
January 5, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Poland,   Russian Federation,   United States
 
 
NCT01349465
CR017365
TMC435HPC3002 ( Other Identifier: Janssen R&D Ireland )
2010-019843-20 ( EudraCT Number )
No
Not Provided
Not Provided
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
March 2017

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