Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
3 de julho de 2015 atualizado por: Boehringer Ingelheim
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
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
131
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Chuo-ku, Chiba, Japão
- 1220.54.08104 Boehringer Ingelheim Investigational Site
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Chuo-ku, Kobe, Hyogo, Japão
- 1220.54.08118 Boehringer Ingelheim Investigational Site
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Fukui, Fukui, Japão
- 1220.54.08108 Boehringer Ingelheim Investigational Site
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Gifu, Gifu, Japão
- 1220.54.08110 Boehringer Ingelheim Investigational Site
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Itabashi-ku, Tokyo, Japão
- 1220.54.08105 Boehringer Ingelheim Investigational Site
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Izunokuni, Shizuoka, Japão
- 1220.54.08112 Boehringer Ingelheim Investigational Site
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Kanazawa, Ishikawa, Japão
- 1220.54.08107 Boehringer Ingelheim Investigational Site
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Kita-gun, Kagawa, Japão
- 1220.54.08120 Boehringer Ingelheim Investigational Site
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Kofu, Yamanashi, Japão
- 1220.54.08109 Boehringer Ingelheim Investigational Site
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Kurume, Fukuoka, Japão
- 1220.54.08123 Boehringer Ingelheim Investigational Site
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Mtsuyama, Ehime, Japão
- 1220.54.08121 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Japão
- 1220.54.08113 Boehringer Ingelheim Investigational Site
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Nishinomiya, Hyogo, Japão
- 1220.54.08117 Boehringer Ingelheim Investigational Site
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Ogaki, Gifu, Japão
- 1220.54.08111 Boehringer Ingelheim Investigational Site
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Oo mura, Nagasaki,, Japão
- 1220.54.08124 Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Japão
- 1220.54.08115 Boehringer Ingelheim Investigational Site
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Osakasayama, Osaka, Japão
- 1220.54.08116 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japão
- 1220.54.08101 Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japão
- 1220.54.08102 Boehringer Ingelheim Investigational Site
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Tanabe, Wakayama, Japão
- 1220.54.08119 Boehringer Ingelheim Investigational Site
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Toyama,Toyama, Japão
- 1220.54.08106 Boehringer Ingelheim Investigational Site
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Tsu, Mie, Japão
- 1220.54.08114 Boehringer Ingelheim Investigational Site
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Yahatanishi-ku, Kitakyusyu, Fukuoka, Japão
- 1220.54.08122 Boehringer Ingelheim Investigational Site
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Yamagata, Yamagata, Japão
- 1220.54.08125 Boehringer Ingelheim Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Patients With Investigator Defined Drug-related Adverse Events
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: EOT (up to Week 24 or 48)
|
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
Prazo: 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)
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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
Prazo: 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)
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Prazo: 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
Prazo: EOT (up to Week 24 or 48)
|
This will be presented as the number of patients.
SVR12 means Sustained virological response 12 weeks post-treatment.
BL = Baseline
|
EOT (up to Week 24 or 48)
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2012
Conclusão Primária (Real)
1 de dezembro de 2013
Conclusão do estudo (Real)
1 de dezembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
12 de abril de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de abril de 2012
Primeira postagem (Estimativa)
18 de abril de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de agosto de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de julho de 2015
Última verificação
1 de julho de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1220.54
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .