E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Virus (HCV) genotype-1 infection |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019744 |
E.1.2 | Term | Hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 |
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFNalfa-2a and RBV, with respect to the proportion of subjects with SVR12 (1) in the subjects who participated in the placebo group of a Phase II/III TMC435 study, and (2) in the subjects who participated in a selected Tibotec-sponsored Phase I study. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
1. To evaluate the antiviral efficacy of TMC435 in combination with PegIFNalfa-2a and RBV with
respect to the proportion of subjects with SVR24.
- To evaluate the antiviral activity to TMC435 in combination with PegIFNalfa-2a and RBV at all time points, with focus on Week 4, Week 12, Week 24, and Week 48.
- To evaluate the incidence of on-treatment failure.
- To evaluate the rate of HCV viral breakthrough during treatment.
- To evaluate the viral relapse rate after treatment.
- To determine the proportion of subjects who meet the criteria for treatment completion at Week 24 in the subgroups of subjects who experienced viral relapse or viral breakthrough in a Phase II/III TMC435 study.
- To determine the viral NS3/4A sequence of subjects not achieving SVR.
- To evaluate the safety and tolerability of TMC435 in combination with PegIFNalfa-2a and RBV. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received
short-term direct-acting antiviral therapy in a Tibotec-sponsored study.
- Liver disease stage documented by liver biopsy is required within 3y ears prior to screening unless contraindicated.
Please refer to the protocol for the complete list of inclusion criteria. |
|
E.4 | Principal exclusion criteria |
- Infection with human immunodeficiency virus. - Liver disease not related to hepatitic C infection.
- Significant laboratory abnormalities or other active diseases.
- Pregnant or planning to become pregnant.
- Prematurely stopped medication in previous TMC435 study for noncompliance or for safety reasons.
Please refer to the protocol for the complete list of exclusion criteria |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants with sustained viral
response |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after planned end of treatment |
|
E.5.2 | Secondary end point(s) |
- The proportion of participants with sustained viral response
- Number of participants with HCV RNA level >1000 IU/mL
- Number of participants with viral breakthrough
- Number of participants with viral relapse
- Number of participants with normalized alanine
aminotransferase levels
- Number of participants with on-treatment failure
- Number of participants affected by an adverse event |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 24 weeks after planned end of treatment
- Week 4
- Through Week 48
- Through Week 48
- Through Week 48
- Through Week 48
- Through Week 48 |
|
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 | Yes |
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
France |
Germany |
Israel |
Italy |
Mexico |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Puerto Rico |
Romania |
Russian Federation |
Slovakia |
Spain |
Turkey |
Ukraine |
United Kingdom |
United States |
|
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
|
Last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |