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

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: No treatment

• Registration Number: NCT01349465
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Study Start: 2011-07-04
• Primary Completion: 2016-01-05
• Study Completion: 2016-01-05
• Results First Submitted: 2016-12-23
• Results First Submitted QC: 2016-12-23
• Results First Posted: 2017-02-16
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: TMC 435 - Patients With SVR at LPVPS	No treatment	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.
Group 2: TMC 435 - Patients With No SVR at LPVPS	No treatment	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining SVR at the Last Available Visit	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).
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	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.
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	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	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

Name	Time	Method
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability	End of study (at month 36)
Percentage of Participants With Late Viral Relapse	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.