E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection |
Infección Crónica de la Hepatitis C |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection |
Infección Crónica 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 | 15.1 |
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 objective of this study are to compare the efficacy (SVR12) and safety of the combination of ABT-450/r/ABT-267 and ABT-333 administered with and without RBV for 12 weeks in treatment-naive HCV genotype 1b-infected adults without cirrhosis. |
El objetivo primario de este estudio es comparar la eficacia (RVS12) y seguridad de la combinación de ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) y ABT-333 administrada con y sin RBV durante 12 semanas de tratamiento en adultos infectados por el VHC del GT 1b, no tratados previamente sin cirrosis. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to compare the percentage of subjects with a decrease in hemoglobin to below the lower limit of normal (LLN) while on treatment between treatment arms and to summarize the percentage of subjects with virologic failure during treatment and the percentage of subjects with relapse post-treatment in each of the treatment group. |
El objetivo secundario de este estudio es comparar, entre los grupos de tratamiento, el porcentaje de sujetos con disminución de la hemoglobina por debajo del límite inferior de la normalidad (LIN) durante el tratamiento y resumir de cada uno de los grupos, el porcentaje de sujetos con fracaso virológico durante el tratamiento y el porcentaje de sujetos con recidiva posterior al tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Males or females 18 and 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 1b-infection (HCV RNA level greater than 10,000 IU/mL at screening) -Subject has never received antiviral treatment for hepatitis C infection -No evidence of liver cirhosis |
Varones o mujeres de 18 a 70 años, ambos inclusive Mujeres deben tener la posmenopausia durante más de 2 años o ser quirúrgicamente estériles o utilizar métodos específicos de control de la natalidad Hepatitis C Crónica, infectados por el genotipo 1b (nivel de ARN del VHC mayor de 10.000 UI/ml en la selección) Pacientes nunca han recibido tratamiento antiviral para la infección de la hepatitis C No evidencia de cirrósis hepática. |
|
E.4 | Principal exclusion criteria |
-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 |
Sensibilidad significativa a cualquier fármaco Uso de medicación contraindicada dentro de las 2 semanas de dosificación Pruebas de laboratorio anormales Resultado positivo para el antígeno de superficie de la hepatitis B (HbsAg) y anticuerpos contra el virus de la inmunodeficiencia humana VIH (Ac anti-VIH). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of subjects in each treatment group with sustained virologic response 12 weeks post-treatment. |
1. Porcentaje de sujetos en cada grupo de tratamiento con respuesta virológica sostenida a las 12 semanas de post-tratamiento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 12 weeks after last dose of study drug. |
1. 12 semanas después de la última dosis del tratamiento. |
|
E.5.2 | Secondary end point(s) |
1. Changes in hemoglobin laboratory values during treatment. 2. Percentage of subjects with virologic failure during treatment. 3. Percentage of subjects with virologic relapse after treatment. |
1. Cambios en los valores de laboratorio referentes a la hemoglobina durante el tratamiento. 2.Porcentaje de sujetos con fracaso virológico durante el tratamiento 3. Porcentaje de sujetos con repunte virológico después del tratamiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. First dose of study drug until last dose of study drug. 2. Post-treatment Day 1 through post-treatment week 48. 3. Post-treatment Day 1 through post-treatment week 48. |
1.Desde la primera dosis de tratamiento hasta la última dosis. 2. Desde el Día 1 de post-tratamiento hasta la semana 48 de post-tramiento. 3. Desde el Día 1 de post-tratamiento hasta la semana 48 de post-tramiento. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
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 | 32 |
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 |
Israel |
Mexico |
Russian Federation |
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 | 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 |