Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Janssen R&D Ireland Identifier:
First received: April 26, 2011
Last updated: January 19, 2016
Last verified: January 2016
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: Interventional
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:

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.

Enrollment: 249
Study Start Date: July 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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
Antwerpen, Belgium
Brugge, Belgium
Brussels, Belgium
Gent, Belgium
Leuven, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Montreal, Canada
Creteil, France
Grenoble, France
Lyon, France
Nice N/A, France
Paris, France
Vandoeuvre-Les-Nancy, France
Berlin, Germany
Düsseldorf, Germany
Frankfurt A. M., Germany
Freiburg, Germany
Hamburg, Germany
Hannover, Germany
Kiel, Germany
Köln, Germany
Würzburg, Germany
Bialystok, Poland
Bydgoszcz, Poland
Czeladz, Poland
Myslowice, Poland
Warszawa, Poland
Russian Federation
Moscow, Russian Federation
Nizhny Novgorod, Russian Federation
Saint-Petersburg, Russian Federation
Samara, Russian Federation
Smolensk, Russian Federation
St Petersburg, Russian Federation
Stavropol, Russian Federation
Sponsors and Collaborators
Janssen R&D Ireland
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

Responsible Party: Janssen R&D Ireland Identifier: NCT01349465     History of Changes
Other Study ID Numbers: CR017365  TMC435HPC3002  2010-019843-20 
Study First Received: April 26, 2011
Last Updated: January 19, 2016
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
Canada: Ethics Review Committee
Germany: Ethics Commission

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on December 08, 2016