E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Virus Infection (Genotype 1b, 2, 3, 4) |
Hepatitis C crónica (genotipo 1b,2,3,4) |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C |
Hepatitis C crónica |
|
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 |
To evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3. |
Evaluar la proporción de sujetos que alcanzan la RVM12 [ARN del VHC < LIDC (objetivo detectado o no)] en la semana 12 de seguimiento postratamiento en sujetos con GT 1b, GT 4 y GT 2, GT 3 |
|
E.2.2 | Secondary objectives of the trial |
1. Proportion of subjects who achieve RVR (HCV RNA < LLOQ target not detected at Week 4) 2. Proportion of subjects who achieve cEVR (HCV RNA < LLOQ target not detected at Week 12) 3. Proportion of subjects who have HCV RNA < LLOQ target not detected at Week 24 4. Proportion of subjects with treatment emergent cytopic abnormalities through end of treatment (Week 12 for GT-2, -3 and Week 24 for GT-1b, -4) 5. Proportion of subjects who experience on-treatment IFN-associated symptoms such as flu-like systems or musculosketletal symptoms through Week 12. 6. Proportion of subjects who achieve SVR24 by treatment group 7. Proportion of subjects with SAEs, discontinuation due to AEs and dose reductions through end of follow-up (maximum of 60 weeks for GT-2, -3 and 72 weeks for GT-1b, -4)
See Protocol sections 1.3.2 for additional objectives. |
?Proporción de sujetos que alcanzan la RVM12 [ARN del VHC < LIDC (objetivo detectado o no)] en la semana 4 ?Proporción de sujetos que consiguen una RVPc (ARN del VHC < LIDC objetivo no detectado en las semana 12) ?Proporción de sujetos que tiene un ARN del VHC < LIDC objetivo no detectado en la semana 24 ?Evaluar la seguridad del tto con Lambda/RBV/DCV a la hora de reducir las anomalías citopénicas surgidas durante el tto (hasta la semana 12 para GT 2,GT 3 y durante la semana 24 para GT 1b,GT 4). ?Evaluar los siguientes síntomas asociados al tto con IFN durante el tto con Lambda/RBV/DCV hasta la semana 12tales como síntomas pseudogripales o musculoesqueléticos ?Evaluar la RVM24 por grupo de tratamiento ?Evaluar la seguridad, medida por la frecuencia de reducciones en la dosis, suspensiones debidas a acontecimientos adversos (AA), y acontecimientos adversos graves (AAG) hasta el final del seguimiento (máximo de 60 semanas para GT 2, GT 3 y 72 semanas para GT 1b, GT 4) |
|
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 |
Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, dated 13-09-12. The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained from the blood sample and health information collected from the main clinical trial, AI452030 to study the association between genetic variation and drug response. |
Enmienda nº 1 de muestra de sangre para Farmacogenética (version 1.0 de fecha 11-sep-2012) El objetivo de esta enmienda es permitir la recogida y el almacenamiento de muestras de sangre para su uso en futuras investigaciones farmacogenética exploratoria. BMS usará ADN obtenido de la muestra de sangre y de la recogida de información sobre salud de los pacientes del ensayo clínico principal, AI452030 para estudiar la asociación entre la variación genética y la respuesta a los fármacos. |
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E.3 | Principal inclusion criteria |
? Infection with the hepatitis C virus (HCV) with underlying mild or moderate hemophilia ? Males 18 years of age and above ? Have not been previously treated with an interferon |
-Pacientes crónicamente infectados por VHC y hemofilia subyacente leve o moderada -Varones de 18 años o mayores. -No hayan sido tratados previamente con interferon |
|
E.4 | Principal exclusion criteria |
? Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) ? Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease ? Presence of Bethesda inhibitor |
-No infectados con VHC, VHD o VIH. -No tener signos de enfermedad hepática, psiquiatrica, sanguínea, de pulmón, tiroides, corazón o de retina. -Presencia del inhibidor Bethesda |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects who achieve SVR12 (HCV RNA < LLOQ target not detected) at post-treatment follow-up Week 12) |
Proporción de sujetos que alcanzan la RVM12 [ARN del VHC < LIDC (objetivo detectado o no)] en la semana 12 de seguimiento postratamiento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Analysis of primary endpoint will be conducted after all subjects reach the Post Dosing Treatment Follow-up Week 12. |
Análisis de la variable principal de valoración se llevará a cabo cuando todos los sujetos alcancen la semana 12 de seguimiento postratamiento |
|
E.5.2 | Secondary end point(s) |
1. Proportion of subjects who achieve RVR (HCV RNA < LLOQ target not detected at Week 4) 2. Proportion of subjects who achieve cEVR (HCV RNA < LLOQ target not detected at Week 12) 3. Proportion of subjects who have HCV RNA < LLOQ target not detected at Week 24 4. Proportion of subjects with treatment emergent cytopic abnormalities through end of treatment (Week 12 for GT-2, -3 and Week 24 for GT-1b, -4) 5. Proportion of subjects who experience on-treatment IFN-associated symptoms such as flu-like systems or musculosketletal symptoms through Week 12. 6. Proportion of subjects who achieve SVR24 by treatment group 7. Proportion of subjects with SAEs, discontinuation due to AEs and dose reductions through end of follow-up (maximum of 60 weeks for GT-2, -3 and 72 weeks for GT-1b, -4) |
?Proporción de sujetos que alcanzan la RVM12 [ARN del VHC < LIDC (objetivo detectado o no)] en la semana 4 ?Proporción de sujetos que consiguen una RVPc (ARN del VHC < LIDC objetivo no detectado en las semana 12) ?Proporción de sujetos que tiene un ARN del VHC < LIDC objetivo no detectado en la semana 24 ?Evaluar la seguridad del tto con Lambda/RBV/DCV a la hora de reducir las anomalías citopénicas surgidas durante el tto (hasta la semana 12 para GT 2,GT 3 y durante la semana 24 para GT 1b,GT 4). ?Evaluar los siguientes síntomas asociados al tto con IFN durante el tto con Lambda/RBV/DCV hasta la semana 12tales como síntomas pseudogripales o musculoesqueléticos ?Evaluar la RVM24 por grupo de tratamiento ?Evaluar la seguridad, medida por la frecuencia de reducciones en la dosis, suspensiones debidas a acontecimientos adversos (AA), y acontecimientos adversos graves (AAG) hasta el final del seguimiento (máximo de 60 semanas para GT 2, GT 3 y 72 semanas para GT 1b, GT 4) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
? Weeks 12 and 24 |
semana 12 y 24 |
|
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 | 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) | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 |
France |
Germany |
Italy |
Netherlands |
Romania |
United States |
|
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
|
LPLV
Analysis of primary endpoint will be conducted after all subjects reach the Week 12 post-treatment follow-up visit. An additional analysis will be conducted when all subjects complete the Week 24 post-treatment follow-up visit. |
última visita de último paciente
Análisis de la variable principal de valoración se llevará a cabo cuando todos los sujetos alcancen la semana 12 de seguimiento postratamiento. Un análisis adicional se llevará a cabo cuando todos los sujetos completen la semana 24 de seguimiento post tratamiento |
|
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 | 5 |
E.8.9.1 | In the Member State concerned days | 26 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 26 |