E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
E.1.2 | System Organ Class | 100000004848 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | 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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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 0 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
France |
Germany |
Poland |
Russian Federation |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |