E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seguimiento a largo plazo de pacientes que han participado en un estudio previo (Long-term Follow-up of prior study participants) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019641 |
E.1.2 | Term | Hepatic cirrhosis |
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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 |
• Confirmar la duración de la respuesta virológica en sujetos con hepatitis C crónica que presentaban una respuesta mantenida 24 semanas después del tratamiento del estudio previo.
• Definir la seguridad a largo plazo en sujetos tratados con SCH 503034 y peginterferón alfa-2b con o sin ribavirina o con peginterferón alfa-2b más ribavirina en un estudio clínico previo en fase 2 ó 3).
• Definir la historia natural de las variantes de la secuencia del VHC en sujetos tratados con SCH 503034 y peginterferón alfa-2b con o sin ribavirina o con peginterferón alfa-2b más ribavirina en un estudio clínico previo en fase 2 ó 3.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Los pacientes debne estar dispuestos a dar su consentimiento informado por escrito y capacitados para seguir el calendario de visitas
- Los pacientes deben de haber recibido al menos una dosis de SCH 503034 más peginterferon alfa-2b con o sin ribavirina, o bien peginterferon alfa-2b más ribavirina en un estudio clínico previo de SPRI en Fase 2 ó 3 donde se haya administrado SCH 503034.
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E.4 | Principal exclusion criteria |
- Participación simultánea en cualquier otro estudio clínico para el tratamiento de la hepatitis crónica C.
- Retratamiento con cualquier fármaco antiviral o inmunomodulador para la hepatitis C crónica tras la finalización o la retirada de un estudio clínico en fase 2 ó 3 de SPRI en el que el sujeto haya participado previamente.
- Cualquier trastorno que, en opinión del investigador, desaconseje la inclusión del sujeto.
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E.5 End points |
E.5.1 | Primary end point(s) |
este estudio tiene tres objetivos principales:
• Confirmar la duración de la respuesta virológica en sujetos con hepatitis C crónica que presentaban una respuesta mantenida 24 semanas después del tratamiento del estudio previo.
• Definir la seguridad a largo plazo en sujetos tratados con SCH 503034 y peginterferón alfa-2b con o sin ribavirina o con peginterferón alfa-2b más ribavirina en un estudio clínico previo en fase 2 ó 3.
• Definir la historia natural de las variantes de la secuencia del VHC en sujetos tratados con SCH 503034 y peginterferón alfa-2b con o sin ribavirina o con peginterferón alfa-2b más ribavirina en un estudio clínico previo en fase 2 ó 3.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Assess durability of response and characterize the natural history of HCV sequence varients |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | Yes |
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 | 6 |
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 |