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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 octubre de 2018 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

158

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Achieving SVR12: Additional Analysis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AbbVie

Investigadores

  • Director de estudio: Andrey Strugovschikov, MD, AbbVie

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de abril de 2016

Finalización primaria (Actual)

4 de julio de 2017

Finalización del estudio (Actual)

4 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

28 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

28 de enero de 2016

Publicado por primera vez (Estimar)

1 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de noviembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de octubre de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • P15-743

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. .

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