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 |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection |
infección crónica 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 | 16.0 |
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 |
The primary objectives of this study are to compare the percentage of
subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-administered with RBV (the DAA combination regimen) to the historical SVR rate of telaprevir plus
pegIFN and RBV therapy and to assess the safety of the DAA
combination regimen versus placebo for 12 weeks in pegIFN/RBV
treatment-experienced HCV genotype 1-infected adults without
cirrhosis. |
Los objetivos principales de este estudio son comparar el porcentaje de sujetos que alcanzan RVS12 (ARN del VHC < límite inferior de cuantificación (LIC) 12 semanas después del tratamiento) de 12 semanas de tratamiento con ABT 450/r/ABT 267 y ABT 333 co-administrados con RBV (la pauta de combinación de AAD) con la tasa histórica de RVS al tratamiento con telaprevir más pegIFN y RBV y evaluar la seguridad de la pauta de combinación de AAD frente a placebo durante 12 semanas en adultos infectados por el VHC de genotipo 1 sin cirrosis que ya han recibido tratamiento previo con pegIFN/RBV. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to measure the effect of the DAA combination regimen compared to placebo for 12 weeks on
normalizing alanine aminotransferase (ALT) levels and demonstrate the effect of the DAA combination regimen on SVR12 in subjects with HCV genotype 1a and genotype 1b infection, and on HCV RNA levels during and after treatment as measured by on-treatment virologic failure and
post-treatment relapse, respectively. |
Los objetivos secundarios de este estudio son medir el efecto de la pauta de combinación de AAD frente a placebo durante 12 semanas sobre niveles normalizados de alanina aminotransferasa (ALT) y demostrar el efecto de la pauta de combinación de AAD sobre RVS12 en sujetos infectados por el VHC de genotipo 1a y genotipo 1b, y sobre los niveles de ARN del VHC durante y después del tratamiento medidos como fracaso virológico durante el tratamiento y recidiva después del tratamiento, respectivamente. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females 18-70 years old, inclusive
- Females must be post-menopausal for more than 2 years or surgically
sterile or practicing specific forms of birth control.
- Chronic hepatitis C, genotype 1 infection
- Failed previous treatment with pegIFN and RBV
- No evidence of liver cirrhosis |
-Varones o mujeres de 18 a 70 años de edad, ambos inclusive.
-Las mujeres deben ser post-menopáusicas más de 2 años o quirúrgicamente estériles o prácticar métodos especificos de control de natalidad.
- Infección crónica por el virus de la hepatitis C (VHC), genotipo 1
- Fracaso del tratamiento previo con pegIFN y RBV
-No evidencia de cirrosis hepática |
|
E.4 | Principal exclusion criteria |
-Positive screen for drugs or alcohol
-Significant sensitivity to any drug
-Use of contraindicated medications within 2 weeks of dosing
-Abnormal laboratory tests
-Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody |
-Resultado positivo en el screening de drogas y alcohol
-Sensibilidad significativa a alguna medicación
- El uso de medicamentos contraindicados en las dos semanas previas a la administración de la medicación del estudio
-Pruebas de laboratorio anormales
-Resultado positivo en el análisis del antígeno de superficie de la hepatitis B Y de anticuerpos contra el virus de la inmunodeficiencia humana VIH |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the percentage of subjects with SVR12. |
El objetivo principal de eficacia es el porcentaje de sujetos que alcanzan una RVS12 . |
|
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 de medicación de estudio. |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints are:
- The percentage of subjects with ALT normalization (ALT ≤ ULN at Final
Treatment Visit for subjects with ALT > ULN at Baseline);
- The percentage of HCV genotype 1a subjects with SVR12;
- The percentage of HCV genotype 1b subjects with SVR12;
- The percentage of subjects with virologic failure during treatment;
- The percentage of subjects with post-treatment relapse.
|
Los criterios de valoración secundarios son:
- Porcentaje de pacientes con normalización de la ALT (ALT ≤ LSN en la visita de final del tratamiento en los sujetos que presentaran una ALT > LSN en el momento basal).
- Porcentaje de pacientes infectados por el VHC de genotipo 1a con RVS12;
- Porcentaje de pacientes infectados por el VHC de genotipo 1b con RVS12;
- Porcentaje de pacientes con fracaso virológico durante el tratamiento.
- Porcentaje de pacientes con recidiva posterior al tratamiento. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- At the end of treatment (last dose of study drug in the trial)
-12 weeks after the last dose of study drug for all HCV genotype 1a
subjects among subjects completing treatment in the active treatment
group.
-12 weeks after the last dose of study drug for all HCV genotype 1b
subjects among subjects completing treatment in the active treatment
group.
- During treatment or at the end of treatment (last dose of study drug)
- At the end of treatment (last dose of study drug in the trial) among
subjects completing treatment in the active treatment group.
- At the end of treatment and between the end of treatment and 12
weeks after the last dose of study drugs among subjects completing
treatment in the active treatment group. |
Al final del tto(última dosis de la medicación del estudio en el ensayo)-12 sem. después de la última dosis de medicación del estudio para los sujetos con VHC genotipo 1a entre los sujetos que completaron el tto en el grupo de tto activo -12 sem. después de la última dosis de medicación del estudio para todos los sujetos con VHC genotipo 1b entre los sujetos que completaron el tto en el grupo de tto activo.- Durante o al final del tto (última dosis de la medicación del estudio) -Al final del tto (última dosis de medicación del estudio en el ensayo) entre los sujetos que completaron el tto en el grupo de tto activo. -Al final del tto y entre el final del tto y 12 sem. después de la última dosis de medicación del estudio entre los sujetos que completaron el tto en el grupo de tto activo. |
|
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 | 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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
12 semanas de periodo doble ciego seguido por 12 semanas de periodo abierto para los sujetos inicial |
12 week double-blind followed by 12 week open label for subjects initially randomized to placebo |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Switzerland |
Turkey |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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 |
Ultima visita del ultimo paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |