E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 | 10022891 - Investigations |
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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 |
Demostrar la superioridad de TMC435 versus placebo como parte de un régimen de tratamiento incluyendo a peginterferon alfa-2a (PegIFN?-2a) y rivavirin (RBV), con respecto a la proporción de sujetos con respuesta virológica sostenida 24 semanasdespués del fin de tratamiento planificado. |
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E.2.2 | Secondary objectives of the trial |
Objetivos secundarios: Se hace referencia en la sección 2 (Objetivos) en las páginas 27 y 28 del protocolo de ensayo clínico. Objetivos exploratorios: Se hace referencia en la sección 2 (Objetivos) en las páginas 27 y 28 del protocolo de ensayo clínico. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Hombres y mujeres mayores de 18 años con biopsia de hígado en las tres semans anteriores a la visita de screening (o entre la visita de screening y la visita basal)con histología consistente con infección crónica de virus de hepatitis C (HCV), sujetos con fibrosis (Matavir Score F3) o Cirrosis (Metavir Score F4) deben tener una prueba de ultrasonido antes de la visita de screening (o entre la visita de screening y la visita basal)sin hallazgos sospechosos de carcinoma hepatocelular, genotipo 1 de virus de hepatitis C (Confirmado en la visita de screening), plasma HCV RNA of > 10,000 IU/mL en la visita de screening y que no tengan tratamiento experimental o comercial en le tratamiento de la hepatitis C |
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E.4 | Principal exclusion criteria |
Evidencia de escompensación hepática. cualquier enfermedad de hígado que no esté relacionada con HCV. Esto incluye hepatitis A, enfermedades del hígado relacionadas con el alcohol o las drogas, hepatitis autoinmune, hemocormatosis, enfermedad de wilson, co-infección con HIVde tipo 1 o de tipo 2 (positivo en el test de HIV de tipo 1 o 2 en la visita de screening), co-infección con el virus de Hepatitis B (hepatitis B surface antigen [HBsAg] positive), condiciones médicas que sean contraindicaciones de PegIFN?-2a o terapia RVB, depresión no controlada, transplante de óganos, enfermedad médica severa como hipertensión, enfermedad coronaria aguda, dibetes poco controlada, enfermadad del tiroides no tratada, infecciones severas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ver sección 11.2.1 del protocolo (página 72) |
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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 | Yes |
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 | Information not present in EudraCT |
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 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |