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Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation (HCV RWE)

18 de outubro de 2018 atualizado por: AbbVie

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

158

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

18 anos a 99 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Descrição

Inclusion Criteria:

Patients are eligible for observation in this cohort if the following applies:

  • Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
  • If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
  • Patients must voluntarily sign and date informed consent prior to inclusion into the study

Exclusion Criteria:

  • Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

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

Coortes e Intervenções

Grupo / Coorte
Participants With Chronic Hepatitis C Genotype 1
Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
Prazo: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
12 weeks after the last actual dose of study drug

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Prazo: 12 weeks after last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough
Prazo: 12 weeks after the last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress
Prazo: 12 weeks after the last actual dose of study drug
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse
Prazo: 12 weeks after last actual dose of study drug
Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
Prazo: 12 weeks after last actual dose of study drug
On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
Prazo: 12 weeks after last actual dose of study drug
12 weeks after last actual dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
Prazo: 24 weeks after last actual dose of study drug
SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment
Prazo: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Virologic response is defined as HCV RNA < 50 IU/mL.
From baseline until end of treatment (12 or 24 weeks after actual first dose)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving SVR12: Additional Analysis
Prazo: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
12 weeks after the last actual dose of study drug
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis
Prazo: 12 weeks after last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis
Prazo: 12 weeks after the last actual dose of study drug
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis
Prazo: 12 weeks after the last actual dose of study drug
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis
Prazo: 12 weeks after last actual dose of study drug
Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
12 weeks after last actual dose of study drug
Percentage of Participants Achieving SVR24: Additional Analysis
Prazo: 24 weeks after last actual dose of study drug
SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis
Prazo: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.
From baseline until end of treatment (12 or 24 weeks after actual first dose)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AbbVie

Investigadores

  • Diretor de estudo: Andrey Strugovschikov, MD, AbbVie

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 (Real)

15 de abril de 2016

Conclusão Primária (Real)

4 de julho de 2017

Conclusão do estudo (Real)

4 de julho de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

28 de janeiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de janeiro de 2016

Primeira postagem (Estimativa)

1 de fevereiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de novembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de outubro de 2018

Última verificação

1 de julho de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • P15-743

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 .

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