E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Virus Genotype 4, 5 or 6 Infection |
Infección crónica por el virus de la hepatitis C genotipos 4,5 o 6 |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection |
Infección crónica 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 | 18.0 |
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 |
|
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 assess the efficacy (SVR12) and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype (GT) 4, 5, or 6 infection without cirrhosis. |
Evaluar la eficacia (RVS12) y seguridad de 12 semanas de tratamiento con un régimen de combinación de ABT-493/ABT-530 en adultos con infección crónica por VHC con genotipos (GT) 4,5 o 6 sin cirrosis. |
|
E.2.2 | Secondary objectives of the trial |
The percentages of subjects with on-treatment virologic failure. The percentage of subjects with post-treatment relapse. |
Establecer el porcentaje de pacientes con fracaso virológico al tratamiento y el porcentaje de pacientes con recaida posterior al tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, at least 18 years of age at time of Screening. 2. Screening laboratory result indicating HCV GT4, 5, or 6 infection. 3. Chronic HCV infection. 4. Subject must be HCV DAA treatment-naïve. 5. Subjects are considered to be non-cirrhotic as per protocol. |
1. Hombres o mujeres mayores de 18 años en el momento de la selección. 2. Resultados de laboratorio en la selección indicando infección por VHC GT4, 5 o 6. 3. Infección crónica por VHC. 4. El paciente no debe haber recibido nunca tratamiento AAD frente a VHC. 5. Los pacientes deben ser considerados no cirróticos como se indica en el protocolo. |
|
E.4 | Principal exclusion criteria |
1. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 3. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 4. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. 5. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. |
1. Mujer embarazada o que planee quedarse embarazada durante el estudio, o amamantando u hombres que son pareja de mujeres embarazadas o que planeen quedarse embarazadas durante el estudio. 2. Paciente con historial reciente de abuso en el consumo de drogas y alcohol (hasta 6 meses antes de la administración del fármaco en estudio) que puedan impedir la adherencia al protocolo según el investigador. 3. Resultados de laboratorio positivos en la selección para el antígeno de superficie de hepatitis B (AgHBs) o anticuerpos frente al virus de la inmunodeficiencia humana (Ac VIH). 4. Genotipo VHC realizado en la selección que indique co-infección con más de un genotipo de VHC. 5. Historial de gravedad, amenaza para la vida u otra sensibilidad significante a cualquier excipiente de los fármacos del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). |
RVS12 (RNA VHC < LLOQ12 semanas después de la última dosis actual del fármaco en estudio). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the last actual dose of study drug. |
12 semanas después de la última dosis actual del fármaco en estudio. |
|
E.5.2 | Secondary end point(s) |
1.The percentage of subjects with on-treatment virologic failure 2. The percentage of subjects with post-treatment relapse |
1. Porcentaje de pacientes con fracaso al tratamiento. 2. Porcentaje de pacientes con recaida en postratamiento. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. During treatment and at the end of treatment with at least 6 weeks of treatment. 2. At the end of treatment and 12 weeks after the last dose of study drug (among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment). |
1. Durante y al final del tratamiento con al menos 6 semanas de tratamiento. 2. Al final del tratamiento y 12 semanas después de la última dosis del fármaco del estudio (en aquellos pacientes que completen el tratamiento como se planea con RNA VHC<LLOQ al final del tratamiento). |
|
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 | 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 | 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 | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
France |
Italy |
Portugal |
South Africa |
Spain |
United Kingdom |
|
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |