E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C |
Hepatitis C Crónica |
|
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 | LLT |
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 compare rates of SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at follow-up Week 12, for genotype 1 patients treated with either BMS-790052 or TVR in combination with pegIFN?-2a/RBV |
Comparar las tasas de RVS12, definida como ARN del VHC < LDC (detectable o indetectable) en la semana 12 de seguimiento, para pacientes de genotipo 1 tratados con BMS-790052 o TVR en combinación con pegIFN-2a/RBV |
|
E.2.2 | Secondary objectives of the trial |
To compare the proportion of patients with : ? hemoglobin laboratory value < 10 g/dL during the first 12 weeks of treatment; ? rash-related dermatologic ?events of special interest? reported during the first 12 weeks of treatment; ? HCV RNA undetectable at Week 12; ? HCV RNA undetectable at Week 4; ? HCV RNA undetectable at Weeks 4 and 12; ? SVR24, defined as HCV RNA < LOQ (detectable or undetectable) at follow-up Week 24; ? SVR12 by IL28B rs12979860 SNP genotype. |
Comparar el porcentaje de pacientes con concentraciones de hemoglobina < 10 g/dl durante las primeras 12 semanas de tratamiento; Comparar el porcentaje de pacientes con ?acontecimientos de especial interés? (AEI) dermatológicos asociados a exantema notificados durante las primeras 12 semanas de tratamiento; Comparar el porcentaje de pacientes con ARN del VHC indetectable en la semana 12; Comparar el porcentaje de pacientes con ARN del VHC indetectable en la semana 4; Comparar el porcentaje de pacientes con ARN del VHC indetectable en las semanas 4 y 12; Comparar el porcentaje de pacientes con RVS24, definida como ARN del VHC < LDC (detectable o indetectable) en la semana 24 de seguimiento; Comparar el porcentaje de pacientes con RVS12 según el genotipo del SNP rs12979860 en el gen IL28B. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects chronically infected with HCV genotype 1 - HCV RNA viral load ? 10,000 IU/mL - No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals - if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year - Body Mass Index (BMI) of 18 to 35 kg/m² - Negative for HIV and Hepatitis B |
-Sujetos infectados crónicamente por el genotipo 1 del VHC ; -ARN del VHC >= 10,000 IU/ml -No existe ningún tratamiento previo incluido y no limitado al tratamiento con interferón, ribavirina y antivirales de acción directa -Si no hay antecedentes de cirrosis, la biopsia hepática a menos de 3 años o Fibroscan ® a menos de 1 año -Índice de Masa Corporal (IMC) de 18 a 35 kg / m² -Seronegatividad para el VIH y el HBsAg |
|
E.4 | Principal exclusion criteria |
- Evidence of decompensated liver disease - Evidence of medical condition contributing to chronic liver disease other than HCV |
-Evidencia de enfermedad hepática descompensada -Evidencia de un trastorno médico que contribuya a la hepatopatía crónica, distinto del VHC |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group |
Porcentaje de pacientes con RVS12, definida como ARN del VHC < LDC en la semana 12 de seguimiento para cada cohorte. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow-up Week 12 |
Semana 12 de seguimiento |
|
E.5.2 | Secondary end point(s) |
Proportion of patients with 1) hemoglobin value less than 10 g/dL 2) rash events 3) HCV RNA undetectable Week 12 4) HCV RNA undetectable Week 4 5) HCV RNA undetectable Weeks 4 and 12 6) SVR24 7) SVR12 based on IL28B genotype |
Porcentaje de pacientes con 1) la hemoglobina valor inferior a 10 g / dl 2) ?acontecimientos de especial interés? dermatológicos asociados a exantema 3) ARN del VHC indetectable en la semana 12 4) ARN del VHC indetectable en la semana 4 5) ARN del VHC indetectable en las semanas 4 y 12 6) RVS24 7) RVS12 según el genotipo IL28B |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Up to Week 12 2) Up to Week 12 3) Week 12 4) Week 4 5) Week 4 and 12 6) Follow-up Week 24 7) Follow-up Week 12 |
1) Hasta la semana 12 2) Hasta la semana 12 3) Semana 12 4) Semana 4 5) Semana 4 y 12 6) Seguimiento en la semana 24 7) Seguimiento en la semana 12 |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Assessments; Virologic Resistance Testing; Serum IP-10 Assessment and Healthcare Resource Utilization Assessment |
Evaluaciones de biomarcadores; Pruebas de resistencia virológica, Evaluación de suero IP-10 y Evaluacion de la utilización de recursos sanitarios |
|
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 |
Austria |
Brazil |
Canada |
Denmark |
France |
Germany |
Israel |
Italy |
Poland |
Russian Federation |
Spain |
Switzerland |
United Kingdom |
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 |
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 | 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 |