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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: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatitis C
 Drug: No treatment
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: July 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who completed the last planned visit of a previous Phase IIb or Phase III study in which they received a TMC435-containing regimen for the treatment of HCV infection

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349465

  Show 45 Study Locations
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

No publications provided

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01349465     History of Changes
Other Study ID Numbers: CR017365, TMC435HPC3002, 2010-019843-20
Study First Received: April 26, 2011
Last Updated: May 6, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration

Keywords provided by Janssen R&D Ireland:
Hepatitis C
Hepatitis
TMC435
Liver disease
Virus Infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013