E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection |
Infección crónica de Hepatitis C |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection |
Infección crónica de Hepatitis C |
|
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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
The primary objective of this study is to evaluate the effect of response to treatment (assessed by SVR12 status) on the long-term progression of liver disease in adults with chronic HCV GT1 infection who received treatment with ABT-450/r/ABT-267 and ABT-333 with or without ribavirin, as measured by all-cause death, liver-related death, liver decompensation, liver transplantation, and hepatocellular carcinoma. |
El objetivo principal de este estudio consiste en evaluar el efecto de la respuesta al tratamiento (evaluada mediante el estado de RVS12) sobre la progresión a largo plazo de la hepatopatía en adultos con infección crónica por el VHC de genotipo 1 (GT1) que hayan recibido tratamiento con ABT 450/r/ABT 267 y ABT 333 con o sin ribavirina, determinado mediante la incidencia de muerte por cualquier causa, muerte de origen hepático, descompensación hepática, trasplante de hígado y carcinoma hepatocelular. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the long-term progression of fibrosis by baseline fibrosis stage and sustained virologic response, as measured by change from baseline in liver stiffness measured by transient elastography (FibroScan®) when available, in adults with genotype 1 (GT1) chronic HCV infection who received treatment with ABT-450/r/ABT-267 and ABT-333 with or without ribavirin.
To evaluate the percentage of subjects achieving SVR12 with ABT-450/r/ABT-267 and ABT-333 with or without ribavirin in adults with GT1 chronic HCV infection |
Evaluar la progresión a largo plazo de la fibrosis en función del estadio de fibrosis basal y la respuesta virológica sostenida (RVS), determinado mediante la variación con respecto al momento basal de la rigidez hepática medida por elastografía transitoria (FibroScan®), cuando esté disponible, en adultos con infección crónica por el VHC GT1 que hayan recibido tratamiento con ABT 450/r/ABT 267 y ABT 333 con o sin ribavirina.
Evaluar el porcentaje de sujetos que logren una RVS12 con ABT 450/r/ABT 267 y ABT333 con o sin ribavirina en adultos con infección crónica por el VHC GT1. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females at least 18 years old at screening 2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control 3. Males must be surgically sterile or agree to practice acceptable forms of birth control 4. Chronic HCV infection prior to study enrollment. 5. Screening laboratory result indicating HCV genotype 1 infection. |
1. Varón o mujer, con una edad mínima de 18 años en el momento de selección. 2. Mujeres en estado posmenopáusico desde al menos 2 años antes de la selección o esterilizadas quirúrgicamente o que estén de acuerdo en utilizar métodos anticonceptivos aceptables. 3. Varones esterilizados quirúrgicamente o que estén de acuerdo en utilizar métodos anticonceptivos aceptables. 4. Infección crónica por el VHC antes de la inclusión en el estudio. 5. Resultado analítico de selección indicativo de infección por el genotipo 1 del VHC. |
|
E.4 | Principal exclusion criteria |
1. Use of contraindicated medication within 2 weeks of dosing 2. Abnormal laboratory tests 3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation 4. Confirmed presence of hepatocellular carcinoma 5. History of solid organ transplant |
1. Uso de la medicación contraindicada en las dos semanas previas a la administración de los fármcos del estudio. 2. Resultados anómalos de laboratorio. 3. Datos clínicos actuales o pasados de la clase B o C de Child Pugh o antecedentes clínicos de descompensación hepática. 4. Presencia confirmada de un carcinoma hepatocelular. 5. Antecedente de trasplante de órgano sólido. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the incidence of all-cause death, liver-related death, liver decompensation, liver transplantation, hepatocellular carcinoma, and the composite of any of the above outcomes observed during the post-treatment period. |
El criterio de valoración principal es la incidencia de muerte por cualquier causa, muerte de origen hepático, descompensación hepática, trasplante de hígado, carcinoma hepatocelular y la combinación de cualquiera de los resultados anteriores durante el periodo posterior al tratamiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drugs |
12 semanas después de la última dosis de los fármacos del estudio. |
|
E.5.2 | Secondary end point(s) |
1. The effect of sustained virologic response and baseline fibrosis stage on longitudinal change from baseline in Fibroscan score (assessed at the end of treatment and/or post-treatment visits) will be evaluated by comparing mean change between subjects who achieve SVR12 and those who do not. Point estimates and 95% confidence intervals will be provided. 2. The percentage of subjects achieving SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). The simple percentage of subjects achieving SVR12 will be calculated and a two-sided 95% confidence interval of the percentage will be computed based on Wilson's score method. |
1. El efecto de la respuesta virológica sostenida y el estadio de fibrosis basal sobre la variación longitudinal con respecto al momento basal de la puntuación Fibroscan (evaluada al final del tratamiento o en visitas posteriores al tratamiento) se evaluará comparando la variación media entre los sujetos que logren una RVS12 y los que no la logren. Se facilitarán estimaciones puntuales e intervalos de confianza del 95%. 2. Porcentaje de sujetos que logren una RVS12 (ARN del VHC < LIC 12 semanas después de la última dosis real del fármaco del estudio). Se calculará el porcentaje simple de sujetos que logren una RVS12, así como un intervalo de confianza del 95% bilateral del porcentaje basándose en el método de puntuación de Wilson. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 12 weeks after the last dose of study drug. 2) 260 weeks after the last dose of study drug. |
1) 12 semanas después de la última dosis de fármaco del estudio. 2) 260 semanas después de la última dosis del fármaco del estudio. |
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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 | 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 | Yes |
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 | Yes |
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 | 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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 120 |
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 |
Algeria |
Australia |
Austria |
Belgium |
Bulgaria |
Canada |
Denmark |
European Union |
Finland |
France |
Germany |
Greece |
Israel |
Mexico |
Netherlands |
Norway |
Poland |
Portugal |
Qatar |
Romania |
Russian Federation |
Saudi Arabia |
Spain |
Sweden |
Switzerland |
Turkey |
United Arab Emirates |
United Kingdom |
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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
|
260 weeks following the last dose |
260 semanas después e la última dosis |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
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 | 7 |
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 |