E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection |
Infección crónica por el virus de la hepatitis C (VHC) |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection |
Infección crónica por el virus de la hepatitis C (VHC) |
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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 | 20.0 |
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 | 100000004848 |
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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 is to assess the steady state AUC and to assess the pharmacokinetics (PK) of ABT-493/ABT-530 in pediatric subjects by age group and to evaluate the safety and tolerability of ABT-493/ABT-530 by age group, cirrhosis status and across all subjects. |
El objetivo principal es evaluar el AUC en estado de equilibrio y evaluar la farmacocinética (PK) de ABT-493 / ABT-530 en sujetos pediátricos por grupo de edad y evaluar la seguridad y tolerabilidad de ABT-493 / ABT-530 por grupo de edad, estado de cirrosis en todos los sujetos. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the efficacy of ABT-493/ABT-530 by assessing the percentage of subjects with sustained virologic response for 12 weeks post treatment (SVR12) in HCV GT1 – 6 infected pediatric subjects, the percentages of subjects with on-treatment HCV virologic failure, the percentages of subjects with post-treatment HCV relapse and the percentages of subjects with new HCV infection (or re-infection) for each age group and overall. Also to assess pharmacokinetics and emergence/persistence of viral variants in subjects with available samples; and assess palatability of pediatric formulation, Cmax and clearance of GLE and PIB. |
Los principales criterios de valoración secundarios serán valorar la eficacia de ABT-493/ABT-530 mediante el porcentaje de pacientes que logren una respuesta viral sostenida a las doce semanas postratamiento (RVS12) en pacientes genotipos 1-6 infectados por VHC, el porcentaje de pacientes que experimenten una recidiva después del tratamiento, el porcentaje de pacientes que experimenten un fracaso virológico durante el tratamiento (es decir, rebote virológico o no consecución de supresión) y el porcentaje de pacientes con una infección nueva por el VHC para cada grupo de edad y en general. También para evaluar la farmacocinética y la aparición / persistencia de variantes virales en sujetos con muestras disponibles; y evaluar la palatabilidad de la formulación pediátrica, Cmax y el aclaramiento de GLE y PIB. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Hepatitis C Virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL. 2. Subject must have a weight consistent with a recommended weight range for their age at the time of screening. Subjects that fall out of the weight band for their age at the time of screening may be screened only into the safety and efficacy parts of the study upon TA MD approval. |
1. Infección por el VHC demostrada por la presencia de anticuerpos anti-VHC positivos y ARN del VHC mayor o igual a 1000 UI/ml. 2. El paciente debe tener un peso compatible con la franja de peso recomendada para la edad en el de la visita de selección. Los pacientes que queden fuera de la franja de peso para la edad en el momento de la selección podrán someterse al proceso de selección únicamente en las partes de seguridad y eficacia del estudio tras obtener la aprobación del director médico del área terapéutica |
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E.4 | Principal exclusion criteria |
1. Females who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for HBV DNA. 3. Participants with other known liver diseases. 4. Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child's class B or C cirrhosis. |
1. Mujeres embarazadas o en período de lactancia. 2. Resultado positivo en el análisis de antígeno de superficie del virus de la hepatitis B (HbsAg) o de ADN del VHB. 3. Pacientes con otras hepatopatías conocidas. 4. Cirrosis descompensada, definida como: presencia de ascitis, antecedentes de hemorragia por varices y valores analíticos compatibles con cirrosis en clase B o C de Child. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary pharmacokinetic endpoint will be steady state AUC of ABT-493 and ABT-530 estimated by non-compartmental pharmacokinetic analysis or population pharmacokinetic analysis. |
El criterio de valoración principal será el AUC en estado de equilibrio de ABT-494 y ABT-530 calculada mediante un análisis de farmacocinética no compartimental o de farmacocinética poblacional. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
An interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects participated in the intensive PK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects in Parts 1 and 2 complete PT Week 12 or prematurely discontinue the study. Final analysis will occur after the completion of the whole study. |
Un primer análisis intermedio tendrá lugar cuando los pacientes de la parte 1 del estudio completen la semana postratamiento 12 o discontinúen prematuramente del estudio. Un segundo análisis intermedio tendrá lugar cuando todos los pacientes que participan en la parte de farmacocinética intensiva de la parte 2 del estudio completen la semana postratamiento 12 o discontinúen prematuramente del estudio. Un tercer análisis intermedio tendrá lugar cuando todos los pacientes de la parte 1 y de la parte 2 del estudio completen la semana postratamiento 12 o discontinúen prematuramente del estudio. El análisis final se realizará tras la finalización del todo el estudio. |
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E.5.2 | Secondary end point(s) |
The main secondary endpoint is Cmax and clearance of ABT-493 and ABT-530. The secondary efficacy endpoints are the percentage of subjects with SVR12, the percentage of subjects with on-treatment virologic failure, the percentage of subjects with post treatment relaspe and the percentage of subjects with new HCV infection at any time up to the last study visit. These will be summarized overall and by age group. |
Los principales criterios de valoración secundarios serán la Cmáx y el aclaramiento de ABT-493 and ABT-530. El criterio de valoración secundario será el porcentaje de pacientes que logren una RVS12, el porcentaje de pacientes que experimenten una recidiva después del tratamiento, el porcentaje de pacientes que experimenten un fracaso virológico durante el tratamiento (es decir, rebote virológico o no consecución de supresión) y el porcentaje de pacientes con una infección nueva por el VHC en cualquier momento hasta la última visita del estudio. Estos serán resumidos en general y por grupo de edad. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
An interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects participated in the intensive PK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects in Parts 1 and 2 complete PT Week 12 or prematurely discontinue the study. Final analysis will occur after the completion of the whole study. |
Un primer análisis intermedio tendrá lugar cuando los pacientes de la parte 1 del estudio completen la semana postratamiento 12 o discontinúen prematuramente del estudio. Un segundo análisis intermedio tendrá lugar cuando todos los pacientes que participan en la parte de farmacocinética intensiva de la parte 2 del estudio completen la semana postratamiento 12 o discontinúen prematuramente del estudio. Un tercer análisis intermedio tendrá lugar cuando todos los pacientes de la parte 1 y de la parte 2 del estudio completen la semana postratamiento 12 o discontinúen prematuramente del estudio. El análisis final se realizará tras la finalización del todo el 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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
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 | 4 |
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 | 16 |
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 |
Canada |
Japan |
Puerto Rico |
Russian Federation |
United States |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
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 | 8 |