E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C virus infection. |
Infección por el virus de la hepatitis C crónica |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C |
Hepatitis C crónica |
|
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 | 19.1 |
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 |
To evaluate the durability of SVR in subjects who achieved SVR at last post-therapy visit of parent study (LPVPS). |
Evaluar la durabilidad de la RVS en sujetos que han logrado la RVS en la última visita de seguimiento posterior al tratamiento del estudio principal (UVPTEP) |
|
E.2.2 | Secondary objectives of the trial |
• The incidence of late viral relapse for subjects who achieved SVR at LPVPS. • Liver disease status for all enrolled subjects. |
• La incidencia de la recaída vírica tardía de los sujetos que lograron una RVS en la UVPTEP • El estado de la hepatopatía de todos los sujetos inscritos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject was randomized to a regimen containing ODV + AL-335 ± SMV in a preceding Phase 2 or Phase 3 study (ie, parent study). 2. Subject received at least 1 dose of ODV + AL-335 ± SMV in the parent study. 3. Subject has completed the LPVPS (ie, the last post-therapy follow-up visit of the parent study) and has not passed 6 ±3 months after the LPVPS, as outlined in the TIME AND EVENTS SCHEDULE outlined in the study protocol 4. Subject has signed an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. |
1. El sujeto fue aleatorizado a una pauta posológica que contenía ODV + AL-335 ± SMV en un estudio en fase II o en fase III anterior (es decir, en el estudio principal). 2. El sujeto recibió al menos 1 dosis de ODV + AL-335 ± SMV en el estudio principal. 3. El sujeto ha completado la UVPTEP (es decir, la última visita de seguimiento posterior al tratamiento del estudio principal) y no ha pasado el periodo de selección de 6 + 3 meses después de la UVPTEP, como se describe en el CALENDARIO DE FECHAS Y ACTIVIDADES como se describe en el protocolo del estudio. 4. El sujeto ha firmado un FCI en el que se indica que entiende el objetivo y los procedimientos necesarios para el estudio y que está dispuesto a participar en él. |
|
E.4 | Principal exclusion criteria |
1. Subject is currently enrolled or plans to enroll in another study with an investigational drug (including investigational vaccines) or an invasive investigational medical device between the LPVPS and Visit 6 of the present study (ie, 36 ±4 weeks after the LPVPS of the parent study). 2. Subject received antiviral or immunomodulating treatment, including therapeutic vaccines, for HCV infection between the LPVPS and the screening visit of the present study, or is planned to receive such treatment during the period of this follow-up study. 3.Subject is not able to adhere to the requirements of the follow-up study. |
1. El sujeto está inscrito actualmente o planea inscribirse en otro estudio con un fármaco en investigación (incluidas vacunas en investigación) o con un dispositivo médico en investigación para una técnica invasiva entre la UVPTEP y la visita 6 del presente estudio (es decir, 36 meses ± 4 semanas después de la UVPTEP del estudio principal). 2. El sujeto ha recibido tratamiento antiviral o inmunomodulador, incluidas vacunas terapéuticas, para la infección del VHC entre la UVPTEP y la visita de selección del presente estudio, o planea recibir dicho tratamiento durante el periodo de este estudio de seguimiento. 3. El sujeto no es capaz de cumplir los requisitos del estudio de seguimiento. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the proportion (%) of subjects maintaining SVR until the end of the long-term follow-up |
El criterio de valoración principal de la eficacia es la proporción (%) de sujetos que mantienen la RVS hasta el final del seguimiento a largo plazo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
until the end of the long-term follow-up |
hasta el final del seguimiento a largo plazo |
|
E.5.2 | Secondary end point(s) |
-The proportion of subjects with late viral relapse among subjects who achieved SVR at LPVPS. -Liver disease status in all subjects who achieved or who did not achieve SVR at LPVPS. |
-La proporción de sujetos con recaída vírica tardía entre los sujetos que lograron una RVS en la UVPTEP. -Estado de la hepatopatía de todos los sujetos que lograron o no la RVS en la UVPTEP. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
until the end of the long-term follow-up |
hasta el final del seguimiento a largo plazo |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
Estudio prospectivo de seguimiento a largo plazo. No se administra MEI |
prospective long-term follow-up study. No IMP is beign administered |
|
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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 |
Belgium |
Canada |
Germany |
Italy |
New Zealand |
Poland |
Singapore |
Spain |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 5 |