E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Infection |
Infección por Hepatitis C |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Infection |
Infección por Hepatitis C |
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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 | 17.0 |
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 |
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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 the safety and to compare 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) of co-formulated Ombitasvir/ABT-450/Ritonavir co-administered with RBV for 12 or 16 weeks to a clinically relevant threshold (based on SVR rates for HCV genotype 4-infected subjects treated with pegIFN/RBV) in HCV genotype 4-infected adults with compensated cirrhosis. |
El objetivo primario de este estudio es asegurar la seguridad y comparar el porcentaje de pacientes que alcanzan la respuesta virológica sostenida a las 12 semanas, RVS12 (ácido ribonucleico VHC (ARN) < límite inferior de cuantificación (LLOQ) a las 12 semanas de tratamiento) de la coformulación Ombitasvir/ABT-450/Ritonavir coadministrado con RBV durante 12 o 16 semanas en un umbral clínicamente relevante (basado en tasas de RVS para pacientes infectados por VHC genotipo 4 tratados con pegIFN/RBV) en adultos infectados por VHC genotipo 4 con cirrosis compensada. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to compare SVR12 between the 12- and 16- week treatment arms, to assess the percentage of subjects with on-treatment virologic failure in each treatment arm, and to assess the percentage of subjects experiencing post-treatment relapse within 12 weeks following end of treatment (Relapse12) in each treatment arm. |
Los objetivos secundarios de este estudio son comparar la RVS12 entre los dos brazos de tratamiento de 12 y16 semanas de tratamiento, para evaluar el porcentaje de pacientes con fallo virológico en tratamiento en cada brazo de tratamiento, y evaluar el porcentaje de pacientes que experimentan recaídas postratamiento durante las 12 semanas posteriores al final del tratamiento (Recaida12) en cada brazo de tratamiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Subjects must meet one of the following: * Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR * Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV); - Chronic HCV genotype 4 infection with cirrhosis. - Subject has plasma HCV RNA level > 1,000 IU/mL at Screening |
Los pacientes deben de cumplir uno de los siguientes: *Pacientes sin tratar: Pacientes que nunca han rebido tratamiento antiviral para la infección por VHC o *Pacientes experimentados (Respuesta nula anterior, Respondedores parciales o Recayentes a IFN/RBV); - Infección por VHC genotipo 4 crónico con cirrosis - Paciente con niveles de ARN VHC en plasma> 1.000 IU/ML en Selección |
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E.4 | Principal exclusion criteria |
-Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) -Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or NS5a inhibitor, either investigational or experimental (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration -Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy -Confirmed presence of hepatocellular carcinoma -Any cause of liver disease other than chronic HCV infection -Abnormal laboratory tests. |
- Resultado positivo en el periodo de selección en la prueba del antígeno de superficie de la hepatitis B (HBsAg) o para anticuerpos contra el virus de la inmunodeficiencia humana (Ac VIH) - Participación actual en otro estudio clínico, inclusión previa en este estudio o uso previo de cualquier inhibidor de la proteasa, inhibidor no nucleósido de la polimerasa, o inhibidor de la NS5a, tanto en investigación como comercializado (incluida la exposición previa a ABT 450 o Ombitasvir), o tratamiento con cualquier fármaco en investigación durante al menos 6 semanas antes de la administración de la medicación del estudio. - Datos clínicos actuales o pasados de clasificación de Child-Pugh B o C o antecedentes clínicos de descompensación hepática, como ascitis, varices esofágicas o encefalopatía hepática. -Presencia confirmada de carcinoma hepatocelular. - Cualquier causa de enfermedad hepática distinta de la infección crónica por el VHC -Pruebas analíticas anormales |
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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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drugs |
12 semanas después de la última dosis con la medicación del estudio |
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E.5.2 | Secondary end point(s) |
a) The percentage of subjects with sustained virologic response 12 weeks post treatment in Arm A (12 weeks treatment) compared to Arm B (16 weeks treatment) b) Percentage of subjects in each treatment arm with on-treatment virologic failure during the Treatment Period c) Percentage of subjects in each arm with post-treatment relapse |
a) Porcentaje de pacientes con respuesta viral sostenida 12 semanas después del tratamiento en el Brazo A (12 semanas de tratamiento) comparado con el Brazo B (16 semanas de tratamiento). b) Porcentaje de pacientes en cada brazo de tratamiento con fallo virológico tratado durante el periodo de tratamiento c) Porcentaje de pacientes de cada brazo que experimenta recidiva en post tratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) 12 weeks after last dose of study drug; b) up to 16 weeks after first dose of study drug c) within 12 weeks after the last dose of study drug |
a) 12 semanas después de la última dosis con la medicación del estudio b) hasta 16 semanas después de la última dosis con la medicación del estudio c) durante al menos 12 semanas después de la última dosis con la medicación del 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 | 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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Threshold based on historical SVR rates |
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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 | 5 |
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 |
Canada |
European Union |
United States |
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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
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |