TMC435HPC3002 - 3-Year Follow up of Patients After Administration of TMC435 for the Treatment of Chronic Hepatitis C.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019843-20-DE

Enrollment

250

Registered

2010-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus (HCV) MedDRA version: 16.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Have previously participated in a Phase II or Phase III study; received at least one dose of TMC435 in that study; completed the last patient visit of the previous study Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device; received antiviral or immunomodulating treatment for HCV between last visit previous study and this study

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the durability of sustained virologic response (SVR) in subjects who were treated with a TMC435- containing regimen in a previous Phase IIb or Phase III study and maintained undetectable HCV ribonucleic acid (RNA) until the last planned visit of that previous study (LPVPS). - To evaluate sequence changes in the HCV NS3/4A region over time in subjects who were treated with a TMC435-containing regimen in a previous Phase IIb or Phase III study and had confirmed detectable HCV RNA at the LPVPS.;Secondary Objective: - To assess the frequency of late relapse (i.e., relapse at any time after the LPVPS until the last individual visit of the present study) and evaluate sequence changes in the HCV NS3/4A region in subjects with late relapse (i.e., subjects with SVR and undetectable HCV RNA at the LPVPS and subsequent relapse). - To assess the development of liver disease progression in subjects previously treated with a TMC435-containing regimen.;Primary end point(s): - Proportion (%) of patients with undetectable HCV RNA (<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;Timepoint(s) of evaluation of this end point: Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study	—

Measure

Time frame

Main Objective: - To evaluate the durability of sustained virologic response (SVR) in subjects who were treated with a TMC435- containing regimen in a previous Phase IIb or Phase III study and maintained undetectable HCV ribonucleic acid (RNA) until the last planned visit of that previous study (LPVPS). - To evaluate sequence changes in the HCV NS3/4A region over time in subjects who were treated with a TMC435-containing regimen in a previous Phase IIb or Phase III study and had confirmed detectable HCV RNA at the LPVPS.;Secondary Objective: - To assess the frequency of late relapse (i.e., relapse at any time after the LPVPS until the last individual visit of the present study) and evaluate sequence changes in the HCV NS3/4A region in subjects with late relapse (i.e., subjects with SVR and undetectable HCV RNA at the LPVPS and subsequent relapse). - To assess the development of liver disease progression in subjects previously treated with a TMC435-containing regimen.;Primary end point(s): - Proportion (%) of patients with undetectable HCV RNA (<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;Timepoint(s) of evaluation of this end point: Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study

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Secondary

Measure	Time frame
Secondary end point(s): - Change in sequence of the HCV NS3/4A region in patients with late relapse, i.e. relapse after the last visit of the previous study - Development of liver disease progression in patients previously treated with a TMC435-containing regimen;Timepoint(s) of evaluation of this end point: - Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study - Starting at screening, and then every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study	—

Measure

Time frame

Secondary end point(s): - Change in sequence of the HCV NS3/4A region in patients with late relapse, i.e. relapse after the last visit of the previous study - Development of liver disease progression in patients previously treated with a TMC435-containing regimen;Timepoint(s) of evaluation of this end point: - Every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study - Starting at screening, and then every six months, starting at six months after the last patient visit of the previous study, and up to three years after the last visit of the previous study

—

Countries

Canada, France, Germany, Poland, Russian Federation, United States

Contacts

Public ContactJanssen Biologics BV

Janssen-Cilag International NV - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com+31071524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026