Clinical Investigation of Erlotinib as an HCV Entry Inhibitor
Palabras clave
Abstracto
fechas
Verificado por última vez: | 05/31/2014 |
Primero enviado: | 04/08/2013 |
Inscripción estimada enviada: | 04/17/2013 |
Publicado por primera vez: | 04/18/2013 |
Última actualización enviada: | 06/13/2014 |
Última actualización publicada: | 06/16/2014 |
Fecha de inicio real del estudio: | 04/30/2013 |
Fecha estimada de finalización primaria: | 04/30/2015 |
Fecha estimada de finalización del estudio: | 04/30/2015 |
Condición o enfermedad
Intervención / tratamiento
Drug: 1- Erlotinib
Drug: placebo
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: 1- Erlotinib Erlotinib is a first class HCV entry inhibitor. In this study, Erlotinib will be administered in escalating doses in sequential patient cohorts for 14 days as follows:
Dose level (DL) 1 = 50 mg / day,
Dose level (DL) 2 = 100 mg / day, and
Dose level (DL) 3 = 150 mg / day .
Each Dose Level (DL) includes 4 patients (3 patients treated with Erlotinib and one patient treated with the Placebo). Dose escalation will proceed to the subsequent DL in the absence of DLT (dose-limiting toxicity) in 2 patients receiving Erlotinib. | Drug: 1- Erlotinib Erlotinib 50 mg tablet by mouth every day for 14 days,
Erlotinib 100 mg tablet by mouth every day for 14 days,
Erlotinib 150 mg tablet by mouth every day for 14 days, |
Placebo Comparator: placebo | Drug: placebo Placebo 50 mg tablet by mouth every day for 14 days,
Placebo 100 mg tablet by mouth every day for 14 days,
Placebo 150 mg tablet by mouth every day for 14 days, |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Chronic genotype 1b hepatitis C infection with detectable HCV RNA (> 1x104 UI/mL) - Naïve, relapser or non-responder to interferon with or without ribavirin - Weight > 45kg, BMI between 18 and 25 Kg/m2 who had a liver biopsy or liver FibroScan eliminating the presence of cirrhosis in the year before enrollment, - Non-smoker or occasional smoker ( ie < 3 cig/day) Exclusion Criteria: - HIV or HBV infection - Cirrhosis or Liver decompensation - Chronic liver disease non related to HCV |
Salir
Medidas de resultado primarias
1. Assessment of virologic response and short-term safety of Erlotinib in patients infected with HCV genotype 1b [14-day assessment study]
Medidas de resultado secundarias
1. Assessment of pharmacokinetics of Erlotinib in HCV-infected patients [14-day assessment study]
Otras medidas de resultado
1. Assessment of Erlotinib in HCV-infected patients and evaluation of drug resistance [14-day assessment study]