A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.
SOF
+ RBV
+ Peg-IFN
Enfermedades Transmisibles+7
+ Infecciones Transmitidas por la Sangre
+ Enfermedades del Sistema Digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 24 de septiembre de 2013
Fecha en la que se inscribió al primer participante.This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 601 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Key Inclusion Criteria: * Male or female, age greater than or equal to 18 years. * Confirmed chronic HCV infection. * Subjects will have cirrhosis status assessment; liver biopsy may be required. * Genotype 2 subjects must have cirrhosis of the liver to be eligible. * Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event * Infection with HCV genotype 2 or 3 as determined at Screening * Body mass index (BMI) greater than or equal to 18 kg/m\^2 * Screening laboratory values within predefined thresholds. * Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC. * Subject must be of generally good health as determined by the Investigator. Key Exclusion Criteria: * Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase * Pregnant or nursing female or male with pregnant female partner * History of any other clinically significant chronic liver disease. * HIV or chronic hepatitis B virus (HBV) infection. * Malignancy with the exception of certain resolved skin cancers. * Chronic use of systemically administered immunosuppressive agents. * Clinically-relevant drug or alcohol abuse. * History of solid organ transplantation. * Current or prior history of clinical hepatic decompensation. * History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. * Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.4 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalGrupo IV
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios