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

March 10, 2017 updated by: Janssen R&D Ireland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
  • Canada
      • Montreal, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Creteil, France
      • Grenoble, France
      • Lyon, France
      • Nice N/A, France
      • Paris, France
      • Vandoeuvre-Les-Nancy, France
  • Germany
      • Berlin, Germany
      • Düsseldorf, Germany
      • Frankfurt A. M., Germany
      • Freiburg, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Kiel, Germany
      • Köln, Germany
      • Würzburg, Germany
  • Poland
      • 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
  • United States
    • California
      • Bakersfield, California, United States
      • La Jolla, California, United States
      • Los Angeles, California, United States
    • Florida
      • Jacksonville, Florida, United States
      • Orlando, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Texas
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Last Available Visit (Month 36 for subjects completing the study)
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.
Baseline and Month 36
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.
Baseline and Month 36
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.
Baseline and Month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of study (at month 36)
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame: End of study (at month 36)
End of study (at month 36)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen R&D Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2011

Primary Completion (Actual)

January 5, 2016

Study Completion (Actual)

January 5, 2016

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017365
  • TMC435HPC3002 (Other Identifier: Janssen R&D Ireland)
  • 2010-019843-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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