E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection and compensated cirrhosis |
Infección Crónica por Hepatitis C y cirrosis compensada. |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection and early liver damage. |
Infección Crónica por Hepatitis C y daño hepático precoz. |
|
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 | 14.1 |
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 assess efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment) and safety of coformulated ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 12 or 24 weeks in HCV genotype 1-infected adults with compensated cirrhosis. |
Los objetivos principales de este estudio son evaluar la eficacia (el porcentaje de pacientes que alcanzan una respuesta virológica sostenida a las 12 semanas, RVS12 (ácido ribonucleico (ARN) del VHC < límite inferior de cuantificación (LIC) 12 semanas después del tratamiento), y la seguridad de ABT-450, ritonavir y ABT-267 coformulados (ABT-450r/ABT-267) y ABT-333 administrados junto con RBV durante 12 o 24 semanas en adultos con infección por el VHC del genotipo 1 y cirrosis compensada |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the rapid virologic response rate (RVR) (the percentage of subjects with HCV RNA < LLOQ at Week 4), the end of treatment response (EOTR) rate (the percentage of subjects with HCV RNA < LLOQ at Week 12 for the 12-week arm or at Week 24 for the 24-week arm) and compare SVR12 between the two arms. |
Los objetivos secundarios de este estudio son evaluar la tasa de respuestas virológicas rápidas (RVR) (el porcentaje de pacientes con ARN del VHC < LIC en la semana 4) y la tasa de respuestas al final del tratamiento (RFDT) (el porcentaje de pacientes con ARN del VHC < LIC en la semana 12 en el grupo de la semana 12 o la semana 24 en el grupo de la semana 24) y comparar la RVS12 entre los dos grupos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Males or 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 (HCV RNA level greater than or equal to 10,000 IU/mL at screening -Subject has either never received antiviral treatment for hepatitis C infection or has received prior pegIFN/RBV treatment and did not respond -Documentation of cirrhosis (Child Pugh A) |
-Hombres o mujeres entre 18 -70 años (ambos incluidos) -Las mujeres deben ser postmenopausicas de mas de dos años, esterilizadas quirurgicamente o que utilicen métodos anticonceptivos específicos. -Hepatisis C crónica, infección genotipo 1 (Niveles HCV RNA mayores o iguales a 10.000 IU/ml en Screening) -Paciente que no haya recibido nunca un tratamiento antiviral para la infección por hepatitis C o haya recibido tratamiento previo con pegIFN/RBV pero no respondiera al tratamiento. -Documentación de cirrosis (Child Pugh A) |
|
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 al análisis de drogas o alcohol. -Sensibilidad significativa a cualquier fármaco. -Uso de fármacos contraindicados dentro de las dos semanas anteriores a iniciar tratamiento. -Pruebas de laboratorio anormales -Antigeno de superficie positivo de Hepatitis B y anticuerpos anti-virus de la inmunodeficiencia humana. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the percentage of subjects with SVR12. |
El criterio de valoración principal es el porcentaje de pacientes con 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 real de la medicación del estudio |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints are: 1. The percentage of subjects with rapid virologic response (HCV RNA < LLOQ at Week 4); 2. The percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment) 3. The comparison of the percentage of subjects with SVR12 between the two arms. |
Los objetivos secundarios son: 1. El porcentaje de sujetos con rápida respuesta virológica (HCV RNA < LLOQ en semana 4) 2. El porcentaje de sujetos con respuesta al fin del tratamiento (HCV RNA < LLOQ al final del tratamiento) 3. La comparación del porcentaje de sujetos con SVR12 en los dos brazos de tratamiento. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 4 weeks after the first dose of study drug; 2. 12 or 24 weeks after the first dose of study drug. 3. 12 weeks after the last dose of study drug for the 12 week arm and 24 weeks after the last dose of study drug for the 24 week arm. |
E.5.2.1 Momento de evaluación de este objetivo: 1. 4 semanas después de la primera dosis del fármaco del estudio. 2. 12 ó 24 semanas después de la primera dosis del fármaco del estudio. 3. 12 semanas después de la última dosis del fármaco del estudio para el brazo de 12 semanas y 24 semanas después de la última dosis del fármaco del estudio para el brazo de 24 semanas. |
|
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 | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
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 |
Puerto Rico |
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 |
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |