E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic HCV Genotype 1 Infection |
Infección crónica por el virus de la hepatitis C genotipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Virus Infection |
Infección por el virus de la 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 show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) after 12 weeks of treatment with the combination regimen ABT-493/ABT-530 to the historical SVR rate established by current approved standard of care regimens for GT1 (ombitasvir/ paritaprevir/ritonavir + dasabuvir ± RBV or SOF/LDV for 12 weeks) |
Mostrar la no inferioridad de las tasas de RVS12 (percentage de pacientes que alcanzan la respuesta virológica sostenida, RVS12 [ARN VHC < LLOQ12 semanas posteriores al tratamiento] tras las 12 semanas de tratamiento con el régimen combinado de ABT-493/ABT-530 frente a la tasa de RVS histórica establecida por el actual régimen de tratamiento aprobado para GT1 (ombitasvir/ paritaprevir/ritonavir + dasabuvir ± RBV o SOF/LDV durante 12 semanas). |
|
E.2.2 | Secondary objectives of the trial |
To show the non-inferiority in SVR12 rates of the ABT-493/ABT-530 regimen for 8 weeks versus 12 weeks of treatment. |
Mostrar la no inferioridad en las tasas de RVS12 del régimen de ABT-493/ABT-530 durante 8 semanas frente a 12 semanas de tratamiento |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
- optional pharmacogenetic - optional pharmacokinetic |
- Farmacogenético. Opcional - Farmacocinético. Opcional |
|
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 GT1 infection. 3. Chronic HCV infection. 4. Subject must be HCV DAA treatment-naïve 5. Subjects must be non-cirrhotic. |
1. Hombres o mujeres mayores de 18 años en el momento de la selección. 2. Resultados de laboratorio indicando infección VHC GT1 3. Infección VHC crónica 4. Pacientes no tratados previamente para VHC con tratamiento AAD 5. Pacientes no cirróticos |
|
E.4 | Principal exclusion criteria |
1. History of severe, life-threatening or other significant sensitivity to any component of the study drug. 2. 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. 3. 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. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. |
1. Historial de gravedad, amenaza para la vida u otra sensibilidad significante a cualquier excipiente de los fármacos del estudio. 2. 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. 3. 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. 4. 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). 5. Genotipo VHC realizado en la selección que indique co-infección con más de un genotipo de VHC. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) in each arm. |
El porcentaje de pacientes con RVS12 (ARN VHC < LLOQ 12 semanas después de la última dosis de tratamiento) en cada brazo. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks following the last dose of study drug |
12 semanas tras la última dósis de tratamiento |
|
E.5.2 | Secondary end point(s) |
? The percentage of subjects with on-treatment virologic failure; ? The percentage of subjects with post-treatment relapse. |
? Porcentaje de pacientes con fallo virológico al tratamiento ? Porcentaje de pacientes con recaida postratamiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
? the percentage of subjects with on-treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, or HCV RNA ? LLOQ at the end of treatment with at least 6 weeks of treatment), and ? the percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA ? LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequence). |
- El porcentaje de pacientes con fallo al tratamiento virológico (definido como una confirmación del incremento de > 1 log10 IU/mL sobre el punto más bajo durante el tratamiento, o ARN VHC ? LLOQ al final del tratamiento con al menos 6 semanas de tratamiento), y
- El porcentaje de pacientes con recaida postratamiento (definido como ARN VHC ? LLOQ entre final de tratamiento y 12 semanas después de la última dosis de tratamiento de estudio entre pacientes que completaron el tratamiento con ARN VHC < LLOQ al final del tratamiento; con fracaso por recaida frente a reinfección basada en secuencia poblacional de VHC). |
|
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 | 2 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 66 |
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 |
Australia |
Canada |
Chile |
Israel |
Korea, Republic of |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Switzerland |
Taiwan |
United States |
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |