Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
  Purpose
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.

Condition Intervention Phase
Hepatitis C
Drug: No treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
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:
  • 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.


Secondary Outcome Measures:
  • 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) ]

Enrollment: 249
Actual Study Start Date: July 4, 2011
Study Completion Date: January 5, 2016
Primary Completion Date: January 5, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01349465

  Show 49 Study Locations
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01349465     History of Changes
Other Study ID Numbers: CR017365
TMC435HPC3002 ( Other Identifier: Janssen R&D Ireland )
2010-019843-20 ( EudraCT Number )
Study First Received: April 26, 2011
Results First Received: December 23, 2016
Last Updated: March 10, 2017

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

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Simeprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017