E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection |
Infección crónica por Hepatitis C |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Virus Infection |
Infección por virus Hepatitis C |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) following 12 weeks of treatment with ABT-493/ABT-530 and to evaluate safety of ABT-493/ABT-530 in adults with chronic HCV GT1, 2, 4, 5 or 6 infection and compensated cirrhosis |
El objetivo primario de este estudio es evaluar el efecto de respuesta al tratamiento mediante la evaluación del porcentaje de pacientes que alcancen respuesta virológica sostenida a 12 semanas (RVS12) tras de 12 semanas de tratamiento con ABT-493/ABT-530 y evaluar la seguridad de ABT-493/ABT-530 en adultos con infección crónica por VHC GT 1, 2, 4, 5 o 6 y cirrosis compensada |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the percentages of subjects with on-treatment virologic failure and the percentages of subjects with post-treatment relapse. Additional objectives are to assess pharmacokinetics and the emergence and persistence of viral variants in this treatment regimen. |
Los objetivos secundarios son: establecer el porcentaje de pacientes con fallo al tratamiento virológico y el porcentaje de pacientes con recaída posterior al tratamiento. Objetivos adicionales son: establecer la farmacocinética y la aparición y persistencia de variantes en esta pauta de tratamiento |
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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 |
2 optional sub-studies. Both substudies are described in the M14-172 Protocol.
Specific purposes of the optional pharmacogenetic sub-study include: ? To find out why some patients with HCV respond better or worse to ABT-493 and ABT-530 or drugs of the same or similar class ? To possibly find out how HCV and related conditions develop and progress and how they can be diagnosed, monitored or treated ? To possibly develop tests that identify which patients are likely to have specific diseases, respond to ABT-493 and ABT-530 or drugs of the same or similar class, or to predict the progression of HCV ? To possibly develop new therapies, research methods or technologies.
Specific purposes of the optional pharmacokinetic sub-study include: ? To further understand how much study drug is in your body and how your body handles the study drugs. |
2 subestudios opcionales. Ambos subestudios están descritos en el Protocolo M14-172.
Los objetivos específicos del subestudio de farmacogenetica opcional incluyen: ?Averiguar por qué algunos pacientes con Hpatitis C responden mejor o peor a ABT-493 y ABT-530 o medicinas de igual o similar clase. ?Intentar averiguar cómo la Hepatitis C y condiciones relacionadas con ella se desarrollan y progresan, y como pueden ser diagnosticados, monitorizados o tratados ?Para, posiblemente, desarrollar las pruebas que identifiquen que pacientes pueden tener enfermedades específicas , responden a ABT-493 Y ABT-530 o medicinas de igual o similar clase , o para predecir la progresión de hepatitis C. ?Para, posiblemente, desarrollar nuevas terapias, métodos de investigación o tecnologías. Los objetivos específicos del subestudio de farmacocinética opcional incluyen: ?Para entender mejor que cantidad del medicamento del estudio hay en el cuerpo y como se asimila en el mismo. |
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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, 2, 4, 5, or 6 infection. 3. Chronic HCV infection. 4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy. Prior HCV treatment with any other approved or investigational medications is not allowed. 5. Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease. |
1. Hombres y mujeres de al menos 18 años de edad en el momento de la selección. 2. Resultados de laboratorio en la selección que indiquen infección por VHC genotipos 1, 2, 4, 5 o 6. 3. Infección crónica por VHC. 4. Los pacientes no deben haber recibido tratamiento previo para el VHC (p.ej. los pacientes no deben haber recibido ninguna dosis de cualquier pauta de producto aprobado o en investigación) o no haber respondido al tratamiento con IFN o pegIFN con o sin RBV, o SOF junto con RBV con terapia con o sin pegIFN. No se permite el tratamiento previo con cualquier otro medicamento aprobado o en investigación. 5. Los pacientes deben documentar que presentan cirrosis compensada y no tener evidencias actuales o anteriores de cirrosis hepática descompensada |
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E.4 | Principal exclusion criteria |
1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. 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. Antecedentes de gravedad, amenaza a la vida u otras sensibilidades graves a cualquier excipiente de los fármacos de estudio. 2. Mujeres embarazadas, que planeen quedarse embarazadas durante el estudio o estén dando de mamar; u hombres cuya mujer esté embarazada o planee quedarse durante el estudio. 3. Antecedentes recientes de abuso de drogas o alcohol (6 meses antes de iniciar la administración del fármaco en estudio), lo cual puede disminuir la adherencia al protocolo en función de la opinión del investigador 4. Resultado positivo en la selección para antígeno de superficie de hepatitis B (AgHBs) o anticuerpos frente al virus de la inmunodeficiencia humana (Ab VIH). 5. Genotipo VHC realizado durante la selección indicando coinfección con más de un genotipo de VHC. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). |
El objetivo de eficacia primario es RVS12 (ARN VHC < LIC 12 semanas después de la última dosis actual del fármaco en estudio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drug |
12 semanas después de la última dosis del fármaco en estudio |
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E.5.2 | Secondary end point(s) |
The secondary efficacy endpoints are: ? the percentage of subjects with on-treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ? 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ? LLOQ at the end of treatment with at least 6 weeks of treatment); ? 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 as planned with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequencing). |
Los objetivos de eficacia secundarios son: ? Porcentaje de pacientes con fracaso virológico durante el tratamiento (definido como confirmación del incremento de >1 log10 IU/ml por encima del valor nadir durante el tratamiento, confirmado por ARN VHC ? LIC al final del tratamiento con al menos 6 semanas de tratamiento); ? Porcentaje de pacientes con recaída posterior al tratamiento (definida como confirmación ARN VHC ? LIC entre el final del tratamiento y 12 semanas después de la última dosis del fármaco en estudio para aquellos pacientes que completen el tratamiento con ARN VHC < LIC al final del tratamiento; con posterior recaída versus reinfección basada en secuenciación de la población VHC). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Treatment Day 1 to end of treatment and end of treatment to 12 weeks after the last dose of study drug. |
Desde el día 1 al final del tratamiento y del final del tratamiento a 12 semanas después de la última dosis del fármaco en 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 | No |
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.8.3 |
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 | 12 |
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 |
South Africa |
Spain |
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
|
last subject last visit (Post-Treatment Week 24). |
Última visita del ultimo paciente incluido (Semana 24 posterior al tratamiento) |
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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 | 1 |
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 | 1 |
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 |