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Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period

6 de mayo de 2016 actualizado por: Bristol-Myers Squibb

Using European data from patients included in the Named Patient Program (NPP) and from the early post-marketing authorization period, the present study aims to describe patient characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in Europe. This will be a retrospective cohort study of patients who received treatment with a DCV-based regimen in the following context:

  • Patients enrolled within the European NPP in one of the following countries Austria, Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or
  • In those countries where DCV is commercially available (ie, Sweden, Germany, United Kingdom), patients who received DCV during the early post-marketing authorization period

The results of this study will contribute to a better understanding of effectiveness of DCV-based regimens in a population that differs from population in the clinical trials, and therefore will provide additional valuable information to inform clinical practice.

This study intends to estimate primarily the effectiveness of DCV-based regimens as measured by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end of Hepatitis C virus (HCV).

This study intends also to describe as secondary objectives the characteristics (ie, demographic and clinical characteristics and treatment patterns of patients starting a new DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based regimens as measured by:

  • On-treatment virological response at post treatment follow-up visit Week 4; and
  • Virological response at the end of treatment (EOT); and
  • The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post treatment follow-up visit Week 24 (SVR24); and
  • The occurrence of virological failure (on-treatment and relapse).

An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the overall population treated with DCV.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

249

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Suiza
      • Basel, Suiza
        • Local Institution

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The study population was selected from European HCV registries or databases in specific health-care facilities from Austria, Denmark, Italy, Sweden, Spain, Switzerland, and United Kingdom (UK)

Descripción

Inclusion Criteria:

  • Patients participating in the DCV NPP from 7 European countries (Austria, Denmark, Italy, Sweden, Spain, Switzerland, and UK). The following patients were eligible to participate in the NPP

    • The patient have a serious or life-threatening condition that is impacting life expectancy within 12 months.
    • There are no comparable or satisfactory alternative treatments options exist for the patient, and/or currently available treatment options have been exhausted.
    • The patient was ineligible to participate in a clinical trial, or there was no ongoing clinical trial in the patient´s country of residence to treat his/her HCV-infection.
  • In countries where DCV is commercially available at time of study initiation(Sweden, UK, and Germany), patients treated with DCV during the early post-marketing authorization period.
  • Patients initiating any DCV-based regimen during the inclusion periods.
  • Recorded in one of the HCV data sources used for the study.

Exclusion Criteria:

  • Patients included in the DCV Compassionate use program (CUP) (AI444-237 Protocol) open in 6 European countries (Germany, Austria, Sweden, Netherlands, Norway and UK) after Committee for Medicinal Products for Human Use (CHMP) opinion for the DCV CUP in Europe will be excluded since these patients will be analyzed as part of separate datasets.

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
Patients treated with DCV (NPP)+Sofosbuvir +/- Ribavirin (RBV)
Patients treated with DCV (NPP) + Simeprevir +/- RBV
Patients treated with DCV(post-marketing) + Sofosbuvir +/- RBV
Patients treated with DCV(post-marketing) + Simeprevir +/- RBV

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
SVR12
Periodo de tiempo: Up to 36 months
Effectiveness of DCV-based regimens as measured by the SVR12, overall and in specific patient sub-populations
Up to 36 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
SVR4
Periodo de tiempo: Up to 36 months
Effectiveness of DCV-based regimens as measured by SVR4
Up to 36 months
SVR24
Periodo de tiempo: Up to 36 months
Effectiveness of DCV-based regimens as measured by SVR24
Up to 36 months
On-treatment Virological response at week 4 assessed by measuring viral load
Periodo de tiempo: Up to 36 months
Up to 36 months
Virological response at the end of treatment (EOT) assessed by measuring viral load
Periodo de tiempo: Up to 36 months
Up to 36 months
The occurrence of virological failure (on-treatment and relapse) assessed by measuring viral load
Periodo de tiempo: Up to 36 months

Virological failure is defined as virologic breakthrough, other on-treatment failure or relapse, where:

  • Virologic breakthrough is defined as confirmed ≥ 1 log10 IU/mL HCV RNA on treatment increase from nadir, or confirmed increase in HCV RNA ≥ LLOQ if HCV RNA previously declined to < LLOQ (TD/TND). (LLOQ: Lower limit of quantification)
  • Relapse is defined as HCV RNA < LLOQ (TND) at End of Treatment followed by confirmed detectable HCV RNA ≥ LLOQ in any follow-up visit window.
  • On-treatment failure is defined as HCV RNA ≥ LLOQ at any time point not meeting the definition of virologic breakthrough or relapse.
Up to 36 months

Colaboradores e Investigadores

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

Patrocinador

Bristol-Myers Squibb

Colaboradores

Basel Institute of Clinical Epidemiology (BICE)

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

1 de marzo de 2015

Finalización primaria (Actual)

1 de febrero de 2016

Finalización del estudio (Actual)

1 de febrero de 2016

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2015

Primero enviado que cumplió con los criterios de control de calidad

21 de agosto de 2015

Publicado por primera vez (Estimar)

24 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de mayo de 2016

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

6 de mayo de 2016

Última verificación

1 de mayo de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AI444-319

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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