E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C |
Hepatitis C Crónica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C |
Hepatitis C Crónica |
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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 | 14.1 |
E.1.2 | Level | LLT |
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 |
To compare rates of SVR12 for Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFN?-2a/RBV. |
Comparar las tasas de SVR12 en sujetos con genotipo 4 del VHC tratados con BMS 790052 o placebo en combinación con Peg-interferón alfa-2a/ribavirina |
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E.2.2 | Secondary objectives of the trial |
? To assess efficacy, as determined by: ? HCV RNA < LOQ at each of the following time points: Weeks 1, 2, 4, 6, 8, and 12; at both Weeks 4 and 12 VR(4&12); EOT (up to 48 weeks); post-treatment Week 24 (SVR24); or post-treatment Week 48 for subjects who achieve VR(4&12); ? HCV RNA undetectable at each of the following time points: Weeks 1, 2, 4, 6, 8, and 12; at both Weeks 4 and 12 VR(4&12); EOT (up to 48 weeks); post-treatment Week 12; post-treatment Week 24; or post-treatment Week 48 for subjects who achieve VR(4&12). ? To assess on treatment safety, as measured by the frequency of Serious Adverse Events (SAEs) and discontinuations due to AEs. ? To assess the relationship between efficacy endpoints and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene. |
?Evaluar la eficacia, determinada por: -ARN del VHC < LDC en cada uno de los siguientes puntos temporales: Semanas 1, 2, 4, 6, 8 y 12; en las semanas 4 y 12 (RV4 y 12); FDT (hasta 48 semanas); semana 24 postratamiento (RVS24); o semana 48 postratamiento en los sujetos que alcancen RV(4 y 12); -ARN del VHC indetectable en los siguientes puntos temporales: Semanas 1, 2, 4, 6, 8 y 12; en las semanas 4 y 12 (RV4 y 12); FDT (hasta 48 semanas); semana 12 postratamiento; semana 24 postratamiento; o semana 48 postratamiento en los sujetos que alcancen RV(4 y 12). ?Evaluar la seguridad del tratamiento, medida por la frecuencia de acontecimientos adversos graves (AAG) y de retiradas debidas a AA. ?Evaluar la relación entre los criterios de valoración de la eficacia y el polimorfismo de un solo nucleótido (SNP) rs12979860 en el gen de IL28B. |
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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 01 (version 1.0 dated 12-Aug-11)
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, AI444042 to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of Hepatitis C. Samples from this study may also be used in conjunction with pharmacogenetic research results from other clinical studies to accomplish this objective. |
Enmienda 1 de muestra de sangre para farmacogenética (version 1.0 de fecha 12-agosto-11)
El objetivo de esta enmienda es permitir la recogida y almacenamiento de muestras de sangre para su uso en futuras investigaciones exploratorias farmacogenética. Bristol-Myers Squibb utilizará ADN obtenido de la muestra de sangre y la información de salud procedentes del ensayo clínico principal, AI444042 para estudiar la asociación entre la variación genética y respuesta a los fármacos. Bristol-Myers Squibb también se puede usar el ADN para estudiar las causas y la progresión de la hepatitis C. Las muestras de este estudio también se puede utilizar en combinación con los resultados de la investigación farmacogenética de otros estudios clínicos para lograr este objetivo. |
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E.3 | Principal inclusion criteria |
? Subjects chronically infected with HCV Genotype 4 ? HCV RNA viral load of ? 10,000 IU/mL ? No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent (DAA). ? Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted. |
Sujetos infectados crónicamente por el genotipo 4 del VHC ?ARN del VHC >= 10,000 IU/ml; ?No tratamiento previo del VHC a base de interferón o antivíricos de acción directa (AAD) sobre el VHC. ?Disponer de una biopsia hepática realizada en los tres años anteriores a la inclusión para demostrar la ausencia de cirrosis. Sujetos que presentan cirrosis están permitidos y es suficiente cualquier biopsia hepática previa. |
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E.4 | Principal exclusion criteria |
? Evidence of decompensated liver disease ? Documented or suspected HCC ? Positive for HBsAg or HIV-1/HIV-2 antibody at screening |
?Evidencia de enfermedad hepática descompensada. ?Hallazgos documentados o sospechosos de CHC ?Positividad para HBsAg, HIV-1 o HIV-2 Ab en el periodo de selección. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare rates of SVR12 for subjects treated with either BMS-790052 or placebo in combination with pegIFN?-2a/RBV. |
Comparar las tasas de SVR12 en sujetos con genotipo 4 del VHC tratados con BMS 790052 o placebo en combinación con Peg-interferón alfa-2a/ribavirina |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 12 follow up |
Semana 12 de seguimiento |
|
E.5.2 | Secondary end point(s) |
1) Proportion of subjects who achieve HCV Ribonucleic acid (RNA) < Limit of quantification (LOQ) 2) Proportion of subjects who achieve HCV RNA undetectable 3) Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for all subjects on treatment 4) Proportion of subjects with SVR12 or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene |
1) Porcentaje de sujetos que alcanzan ARN del VHC < LDC 2) Porcentaje de sujetos que alcanzan ARN del VHC indetectable 3) Frecuencia de AAG y retiradas debidas a AA para todos os sujetos en tratamiento 4) Porcentaje de sujetos con SVR12 o SVR24 por el polimorfismo de un solo nucleótido (SNP) rs12979860 en el gen de IL28B |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12; EOT (up to 48 weeks); post-treatment week 24 (SVR24); or post-treatment Week 48 for subjects who achieve Virologic response at week 4 and week 12 [VR(4&12)] defined as HCV RNA undetectable at weeks 4 and 12 2) Weeks 1, 2, 4, 6, 8, and 12; at both weeks 4 and 12 (VR4&12); EOT; post-treatment week 12; post-treatment week 24; or post-treatment Week 48 for subjects who achieve VR(4&12) 3) Maximum of 48 weeks 4) Post-treatment week 12 and post treatment week 24 |
1) Semanas 1, 2, 4, 6, 8 y 12; en las semanas 4 y 12; FDT (hasta 48 semanas); semana 24 postratamiento(SVR24); o semana 48 postratamiento en los sujetos que alcancen Respuesta Virológica (VR4 y 12) definida como ARN del VHC indetectable en las semanas 4 y 12 2) Semanas 1, 2, 4, 6, 8 y 12; en las semanas 4 y 12 (RV4 y 12); FDT; semana 12 postratamiento; semana 24 postratamiento o semana 48 postratamiento en los sujetos que alcancen RV(4 y 12) 3) Máximo de 48 semanas 4) Semana 12 post-tratamiento y semana 24 post-tratamiento |
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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 | 16 |
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 |
Argentina |
Brazil |
Canada |
France |
Italy |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Spain |
Turkey |
United Kingdom |
United States |
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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
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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 | 2 |
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 | 2 |
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 |