E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Infection |
Infección por Hepatitic C |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Infection |
Infección por Hepatitic C |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 is to assess the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV ribonucleic acid {RNA} < lower limit of quantification {LLOQ} 12 weeks following treatment]) of coformulated ombitasvir/paritaprevir/ritonavir and dasabuvir for 8 weeks in treatment-naïve adults with HCV genotype 1b infection without cirrhosis. |
El objetivo primario del estudio es evaluar la eficacia (porcentaje de pacientes que alcanzan la respuesta virológica sostenida a la semana 12, RVS12 [Ácido ribonucleico (ARN) VHC <límite inferior de cuantificación (LOQ12) a las 12 semanas posteriores al tratamiento] con la coformulación de ombitasvir/paritaprevir/ritonavir y dasabuvir durante 8 semanas de tratamiento en pacientes adultos con infección por el virus de la Hepatitis C Genotipo 1 sin cirrosis no tratados previamente. |
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E.2.2 | Secondary objectives of the trial |
? Secondary objectives are to assess the percentage of subjects with virologic failure during treatment, the percentage of subjects with virologic relapse post-treatment, and the percentage of female subjects with SVR12 and the percentage of subjects with low baseline viral load (HCV RNA < 6,000,000 IU/mL) with SVR12 in previously untreated adults with genotype 1b HCV infection. |
?Los objetivos secundarios son evaluar el porcentaje de pacientes con fallo virológico durante el tratamiento, el porcentaje de pacientes femeninas con RVS12 y el porcentaje de pacientes con carga viral basal baja (VHC ARN < 6.000.000 IU/mL) con RVS12 pacientes adultos con infección VHC genotipo 1b no tratados previamente |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female at least 18 years of age at time of Screening. 2. HCV infection at Screening defined as: Positive for anti-HCV antibody (Ab) at Screening and HCV RNA > 1,000 IU/mL at Screening 3. Screening laboratory result indicating HCV genotype 1b infection only 4. Subject has never received commercial or investigational anti-HCV agents for hepatitis C infection (treatment-naïve subject). 5. Absence of cirrhosis, as documented by meeting one of the following criteria (per local standard practice): ? A liver biopsy within 12 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a METAVIR Score of 3 or less, Ishak score of 4 or less; ? A FibroScan performed within 3 months prior to or during screening with a score of < 12.5 kPa; or ? A screening FibroTest score of ? 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ? 2 (Subjects with a screening FibroTest result that is ? 0.72 and an APRI > 2, or a FibroTest result that is > 0.72 and an APRI ? 2 must have a FibroScan or liver biopsy performed during screening to document absence of cirrhosis. These subjects will be allowed to enroll only with approval of the AbbVie Scientific Director). If more than one method is used to determine the presence or absence of cirrhosis, the results of a liver biopsy will take precedence over FibroScan and FibroTest and the results of FibroScan will take precedence over FibroTest. |
1. Hombres o mujeres de al menos 18 años de edad en Selección 2. Infección VHC en Selección definida como: Positivo para anticuerpo anti VHC (Ab) en Selección y ARN VHC > 1.000 IU/mL en Selección 3. Resultados de laboratorio en Selección indicadores de VHC genotipo 1b únicamente 4. Paciente que nunca ha recibido agentes anti VHC para Hepatitis C comercial o en investigación (pacientes sin tratamiento previo). 5. Ausencia de cirrosis, documentado como cumplimiento de uno de los siguientes criterios (por práctica habitual local): ? Biopsia hepática en los 12 meses previos o durante la selección que demuestre la ausencia de cirrosis, ej, una puntuación de METAVIR de 3 o menos, Puntuación Ishak de 4 o menos; ? Un fibroScan realizado durante los 3 meses antes o durante la selección con una puntuación de < 12,5 kPa; o ? Una puntuación de FibroTest de ? 0.72 y APRI ? 2 (Pacientes con un resultado de FibroTest en Selección ? 0.72 y un APRI > 2, o un resultado de FibroTest > 0.72 y un APRI ? 2 deben tener un FibroScan o una biopsia hepática realizada durante la selección para documentar la ausencia de cirrosis. Estos resultados serán permitidos para incluir pacientes solo con la aprobación del Director Médico de Abbvie del estudio). Si más de un método es utilizado para determinar la presencia o ausencia de cirrosis, el resultado de la biopsia hepática tendrá prevalencia sobre el FibroScan y FibroTest y el resultado del FibroScan prevalecerá sobre el FibroTest. |
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E.4 | Principal exclusion criteria |
1. Evidence of HCV genotype or subtype other than GT1b during screening, including the presence of GT1b with another genotype or GT1 subtype. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) (test). 3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices or prior biopsy showing cirrhosis. 4. Screening laboratory analyses showing any of the following abnormal laboratory results: ? Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min ? Albumin < 3.5 g/dL ? Hemoglobin < 10 g/dL ? Platelets < 120,000 cells per mm3 ? Total bilirubin ? 3.0 mg/dL ? International normalized ratio (INR) > 1.5. Subjects with a known inherited blood disorder and INR > 1.5 may be enrolled with permission of the AbbVie Scientific Director. 5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the subject an unsuitable candidate for this study or to receive ombitasvir/paritaprevir/ritonavir or dasabuvir in the opinion of the investigator. |
1. Evidencia de genotipo o subgenotipo VHC diferente de GT1b durante selección, incluyendo la presencia de GT1b con otro genotipo o GT1 subgenotipo 2. Resultado positive para antígeno de superficie de la Hepatitis B (HbsAg) o confirmación positiva del anticuerpo anti VHC (Ac VIH ) (prueba). 3. Cualquier evidencia actual o pasada de cirrosis como ascitis o varices esofágicas o biopsia previa que muestra cirrosis 4. Análisis de laboratorio en selección que muestren cualquiera de los siguientes resultados anormales: ? Cálculo de aclaramiento de creatinina (utilizando método Cockcroft-Gault) < 30 ml/min ? Albumina < 3,5 g/dL ? Hemoglobina < 10 g/dL ? Plaquetas < 120.000 celulas por mm3 ? Bilirrubina total ?3.0 mg/dL ? Radio normalizado internacional (RNI) > 1,5. Pacientes con un trastorno hereditario conocido y RNI > 1,5 podrían ser incluidos con el permiso de Director Científico de Abbvie. 5. Anormalidades clínicamente significativas o comorbilidades, otras diferentes a la infección por VHC que hagan al paciente inadecuado para este estudio o para recibir ombitasvir/paritaprevir/ritonavir o dasabuvir en opinión del investigador |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is number and percentage of ITT subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drugs). |
A variable principal de eficacia es un número y un porcentaje de ITT pacientes con RVS12 (ARN VHC < LLOQ12 semanas después de la última dosis de la medicación de estudio). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the last subject last dose |
12 semanas después de la última dosis del último paciente |
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E.5.2 | Secondary end point(s) |
1. The percentage of subjects with on-treatment virologic failure, defined as confirmed HCV RNA ? LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase of at least 1 log10 IU/mL from nadir during treatment, failure to suppress during treatment (all on-treatment values of HCV RNA ? LLOQ) among subjects with at least 6 weeks (active study drug duration ? 36 days) of treatment; 2. The percentage of subjects with post-treatment relapse, defined as confirmed HCV RNA ? LLOQ between end of treatment and 12 weeks after last dose of study drug (up to and including the SVR12 assessment time point) among subjects completing treatment and with HCV RNA < LLOQ at the end of treatment. 3. The percentage of female subjects with SVR12. 4. The percentage of subjects with baseline HCV RNA < 6,000,000 IU/mL with SVR12. |
1. El porcentaje de pacientes con fallo virológico en tratamiento, definido como la confirmación de ARN VHC ? LLOQ después de ARN VHC < LLOQ durante el tratamiento, o un incremento confirmado de al menos 1 log10 IU/mL desde el punto más bajo durante el tratamiento, fracaso a la supresión durante el tratamiento (todos los valores en tratamiento de ARN VHC ? LLOQ) entre los sujetos con al menos 6 semanas (fármaco de estudio activo ? 36 dias) de tratamiento; 2. El porcentaje de pacientes con racaida después del tratamiento, definido como ARN VHC ?LLOQ entre el final del tratamiento y 12 semanas después de la última dosis de la medicación de estudio (hasta e incluyendo el momento de la evaluación de la RVS12) entre los pacientes que completaron el tratamiento y con ARN VHC < LLOQ al final del tratamiento. 3. El porcentaje de mujeres con RVS12 4. El porcentaje de pacientes con ARN VHC < 6.000.000 IU/mL con RVS12 12 semanas después de la última dosis del ultimo paciente |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the last subject last dose |
12 semanas después de la última dosis del último paciente |
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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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
Israel |
Italy |
Spain |
United Kingdom |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |