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

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2010-019843-20-PL
• Date of registration: 17/09/2010
• Prospective Registration: Yes
• Primary sponsor: Janssen R&D Ireland
• Public title: TMC435HPC3002 - 3-Year Follow up of Patients After Administration of TMC435 for the Treatment of Chronic Hepatitis C.
• Scientific 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
• Date of first enrolment: 07/12/2010
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019843-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

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

Contacts

• Name: Janssen Biologics BV
• Affiliation: Janssen-Cilag International NV - Clinical Registry Group

• Name: Janssen Biologics BV
• Affiliation: Janssen-Cilag International NV - Clinical Registry Group

Key inclusion & exclusion 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Hepatitis C Virus (HCV)
MedDRA version: 15.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848

Intervention(s)

Product Name: TMC435 or R494617
Product Code: TMC435 or R494617, formulation F021
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: simeprevir
CAS Number: 923604-59-5
Current Sponsor code: TMC435
Other descriptive name: R494617 or JNJ-38733214-AAA
Concentration unit: MBq/mg megabecquerel(s)/milligram
Concentration type: equal
Concentration number: 75-

Product Name: TMC435 or R494617
Product Code: TMC435 or R494617, formulation F021
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: simeprevir
CAS Number: 923604-59-5
Current Sponsor code: TMC435
Other descriptive name: R494617 or JNJ-38733214-AAA
Concentration unit: MBq/mg megabecquerel(s)/milligram
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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

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).

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

Secondary Outcome(s)

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

Secondary ID(s)

2010-019843-20-DE

TMC435HPC3002

Source(s) of Monetary Support

Tibotec Pharmaceuticals