E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HEPATITIS C VIRUS |
Virus de la hepatitis C |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive. |
Estimar la eficacia, determinada por el porcentaje de pacientes con RVM12, definida como ARN del VHC < LDC en la semana 12 postratamiento en pacientes con respuesta previa nula o parcial a P/R o naive a tratamiento. |
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E.2.2 | Secondary objectives of the trial |
? Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R; ? On treatment safety, as measured by frequency of SAEs and discontinuations due to AEs through the end of treatment plus 7 days; |
?Porcentaje de pacientes tratados con RVM12, definida como ARN del VHC < LDC en la semana 12 postratamiento para los pacientes con intolerancia o que no son elegibles para P/R; ?Seguridad del tratamiento, medida por la frecuencia de AAG y abandonos debido a AA hasta el final del tratamiento más 7 días |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Males and females, ? 18 years of age; ? HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with cirrhosis, OR treatment naive; ? HCV RNA ? 104 IU/mL (10,000 IU/mL); ? Seronegative for HIV and HBsAg; ? Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population). |
?Hombres y mujeres, ?18 años; ?VHC de genotipo 1b que previamente no han respondido al tratamiento con P/R, clasificados como pacientes con respuesta nula o parcial basándose en el tratamiento previo o con intolerancia o no elegible para P/R debido a neutropenia, anemia, depresion o trombocitopenia con cirrosis o tatamiento naive . ?ARN del VHC ? 104 UI/ml (10.000 UI/ml); ?Seronegatividad para VIH y HBsAg; ?Pacientes con cirrosis compensada (el número de cirróticos compensados se limita cuando se alcance aproximadamente el 25% de la población tratada) |
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E.4 | Principal exclusion criteria |
? Prior treatment of HCV with HCV direct acting antiviral (DAA); ? Evidence of a medical condition contributing to chronic liver disease other than HCV; ? Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy; ? Diagnosed or suspected hepatocellular carcinoma or other malignancies; ? Uncontrolled diabetes or hypertension; |
?Tratamiento previo con antivirales de acción directa (AAD) contra el VHC; ?Indicios de un trastorno médico que contribuya a la hepatopatía crónica, distinto del VHC; ?Indicios de enfermedad hepática descompensada incluidos, entre otros, antecedentes de o presencia de ascitis, varices hemorrágicas o encefalopatía hepática; ?Diagnóstico o sospecha de carcinoma hepatocelular u otros tumores; ?Diabetes o hipertensión no controladas; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects who are prior null or partial responders to P/R or are treatment-naive. |
?Porcentaje de pacientes tratados con RVM12, definida como ARN del VHC < LDC en la semana 12 postratamiento, para todos pacientes con respuesta nula o parcial previa a P/R o naive al tratamiento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 12 weeks post-treatment |
semana 12 postratamiento |
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E.5.2 | Secondary end point(s) |
? Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R; ? On treatment safety, as measured by frequency of SAEs and discontinuations due to AEs through the end of treatment plus 7 days; |
?Porcentaje de pacientes tratados con RVM12, definida como ARN del VHC < LDC en la semana 12 postratamiento para los pacientes con intolerancia o que no son elegibles para P/R; ?Seguridad del tratamiento, medida por la frecuencia de AAG y abandonos debido a AA hasta el final del tratamiento más 7 días; |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
? Post-treatment Week 12; ? Through the end of treatment (maximum of 48 weeks) plus 7 days; |
.?semana 12 postratamiento ? Durante y hasta el final del tratamiento(maximo 48 semanas) más 7 días; |
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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 | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
tratamiento para los pacientes de las cohortes de respuesta nula o parcial o con intolerancia o no e |
Open and single group for Null/partial responder and intolerant/ineligible cohorts |
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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 | 24 |
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 |
Australia |
Brazil |
Canada |
Israel |
Korea, Republic of |
New Zealand |
Poland |
Russian Federation |
Singapore |
Taiwan |
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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The last visit will be considered the date of the last post-treatment visit. The end of the study will be considered the last subject?s last visit date, or the date the last data point required for statistical analysis is received from the last subject in the null or partial responder or treatment-naive cohort, whichever is later. The final analysis will occur once all subjects complete post-treatment Week 24. |
La última visita se considerará la fecha de la última visita de post-tratamiento. El final del estudio se considerará la fecha del última visita del ultimo paciente, o la fecha de los últimos datosrequeridos para el análisis estadístico se recibe desde el último paciente de la nula o parcial de respuesta o tratamiento previo de cohorte, que sea posterior. El análisis final se producirá una vez completen todos los pacientes el post-tratamiento de 24 semanas. |
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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 | 6 |
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 | 6 |