- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01579474
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Chuo-ku, Chiba, Japón
- 1220.54.08104 Boehringer Ingelheim Investigational Site
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Chuo-ku, Kobe, Hyogo, Japón
- 1220.54.08118 Boehringer Ingelheim Investigational Site
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Fukui, Fukui, Japón
- 1220.54.08108 Boehringer Ingelheim Investigational Site
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Gifu, Gifu, Japón
- 1220.54.08110 Boehringer Ingelheim Investigational Site
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Itabashi-ku, Tokyo, Japón
- 1220.54.08105 Boehringer Ingelheim Investigational Site
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Izunokuni, Shizuoka, Japón
- 1220.54.08112 Boehringer Ingelheim Investigational Site
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Kanazawa, Ishikawa, Japón
- 1220.54.08107 Boehringer Ingelheim Investigational Site
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Kita-gun, Kagawa, Japón
- 1220.54.08120 Boehringer Ingelheim Investigational Site
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Kofu, Yamanashi, Japón
- 1220.54.08109 Boehringer Ingelheim Investigational Site
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Kurume, Fukuoka, Japón
- 1220.54.08123 Boehringer Ingelheim Investigational Site
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Mtsuyama, Ehime, Japón
- 1220.54.08121 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Japón
- 1220.54.08113 Boehringer Ingelheim Investigational Site
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Nishinomiya, Hyogo, Japón
- 1220.54.08117 Boehringer Ingelheim Investigational Site
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Ogaki, Gifu, Japón
- 1220.54.08111 Boehringer Ingelheim Investigational Site
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Oo mura, Nagasaki,, Japón
- 1220.54.08124 Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Japón
- 1220.54.08115 Boehringer Ingelheim Investigational Site
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Osakasayama, Osaka, Japón
- 1220.54.08116 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japón
- 1220.54.08101 Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japón
- 1220.54.08102 Boehringer Ingelheim Investigational Site
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Tanabe, Wakayama, Japón
- 1220.54.08119 Boehringer Ingelheim Investigational Site
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Toyama,Toyama, Japón
- 1220.54.08106 Boehringer Ingelheim Investigational Site
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Tsu, Mie, Japón
- 1220.54.08114 Boehringer Ingelheim Investigational Site
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Yahatanishi-ku, Kitakyusyu, Fukuoka, Japón
- 1220.54.08122 Boehringer Ingelheim Investigational Site
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Yamagata, Yamagata, Japón
- 1220.54.08125 Boehringer Ingelheim Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
- liver biopsy consistent with chronic HCV infection.
- HCV genotype 1 infection confirmed by genotypic testing at screening
- (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
- HCV RNA = 100,000 IU/mL at screening
- Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
- Age 20 to 70 years
Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
- Signed informed consent form before trial participation
Exclusion criteria:
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.
- HIV co-infection,
- Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
- Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix),
- Active or, history of alcohol or illicit drug abuse within the past 12 months,
- A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study,
- Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
- Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
- (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
- Known hypersensitivity to any ingredient of the study drugs,
- Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2),
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1. BI 201335 low dose plus PegIFN/RBV
low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
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BI 201335 low dose with PegIFN/RBV
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Experimental: 2. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
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BI 201335 high dose with PegIFN/RBV
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Experimental: 3. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
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BI 201335 high dose with PegIFN/RBV
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Experimental: 4. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
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BI 201335 high dose with PegIFN/RBV
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Patients With Investigator Defined Drug-related Adverse Events
Periodo de tiempo: Up to 52 weeks
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Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
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Up to 52 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Periodo de tiempo: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
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Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
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EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
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Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
Periodo de tiempo: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
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Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
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EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
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Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
Periodo de tiempo: up to 8 weeks
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Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
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up to 8 weeks
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Periodo de tiempo: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Periodo de tiempo: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Periodo de tiempo: 12 weeks after the EOT (up to Week 36 or 60)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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12 weeks after the EOT (up to Week 36 or 60)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Periodo de tiempo: 12 weeks after the EOT (up to Week 36 or 60)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks after the EOT (up to Week 36 or 60)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Periodo de tiempo: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Periodo de tiempo: EOT (up to Week 24 or 48)
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This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
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EOT (up to Week 24 or 48)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Periodo de tiempo: 12 weeks after the EOT (up to Week 36 or 60)
|
This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks after the EOT (up to Week 36 or 60)
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Periodo de tiempo: 12 weeks after the EOT (up to Week 36 or 60)
|
This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
|
12 weeks after the EOT (up to Week 36 or 60)
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1220.54
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Hepatitis C
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Trek Therapeutics, PBCTerminadoHepatitis C Crónica | Hepatitis C Genotipo 1 | Hepatitis C (VHC) | Infección viral de la hepatitis CEstados Unidos, Nueva Zelanda
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Trek Therapeutics, PBCTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 4 | Infección viral de la hepatitis CEstados Unidos
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AbbVieTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 1a
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AbbVie (prior sponsor, Abbott)TerminadoHepatitis C Crónica | Hepatitis C Genotipo 1 | Hepatitis C (VHC)Estados Unidos, Australia, Canadá, Francia, Alemania, Nueva Zelanda, Puerto Rico, España, Reino Unido
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AbbVieTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 1a
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Humanity and Health Research CentreBeijing 302 HospitalTerminadoInfección crónica por hepatitis CPorcelana
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University Health Network, TorontoTerminadoInfección crónica por hepatitis CCanadá
-
AbbVie (prior sponsor, Abbott)TerminadoHepatitis C | Infección crónica por hepatitis C | VHC | Hepatitis C Genotipo 1Estados Unidos, Puerto Rico
-
AbbVieTerminadoVirus de la hepatitis C | Virus de la hepatitis C crónica
-
AbbVie (prior sponsor, Abbott)TerminadoHepatitis C | Infección crónica por hepatitis C | VHC | Hepatitis C Genotipo 1Estados Unidos
Ensayos clínicos sobre BI 201335 low dose
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminadoHepatitis C CrónicaEstados Unidos, Argentina, Australia, Austria, Canadá, República Checa, Francia, Alemania, Corea, república de, Países Bajos, Portugal, Rumania, España, Suiza, Reino Unido
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminadoHepatitis C CrónicaEstados Unidos, Austria, Canadá, Francia, Alemania, Hungría, Irlanda, Italia, Países Bajos, Portugal, Rumania, Federación Rusa, España, Reino Unido
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminadoCirrosis hepática | Hepatitis CAlemania
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado