Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

9 de julio de 2014 actualizado por: Vertex Pharmaceuticals Incorporated

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

117

Fase

  • Fase 2

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

  • Alemania
      • Berlin, Alemania
      • Bonn, Alemania
        • Universitatsklinikum Bonn
      • Cologne, Alemania
        • University of Cologne
      • Dusseldorf, Alemania, 40225
        • Uniklinik Duesseldorf
      • Frankfurt, Alemania
      • Hannover, Alemania
  • Austria
      • Vienna, Austria
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá
        • University of Calgary Medical Clinic
      • Edmonton, Alberta, Canadá
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canadá
        • University of British Columbia Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canadá
    • Ontario
      • Toronto, Ontario, Canadá
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos
      • San Diego, California, Estados Unidos
        • Kaiser Permanente Internal Medicine
      • San Francisco, California, Estados Unidos
    • Colorado
      • Denver, Colorado, Estados Unidos
        • University of Colorado Health Sciences Center
      • Englewood, Colorado, Estados Unidos
        • South Denver Gastroenterology
    • Florida
      • Gainesville, Florida, Estados Unidos
        • University of Florida
      • Jacksonville, Florida, Estados Unidos
        • Borland-Groover Clinic
      • Jacksonville, Florida, Estados Unidos
        • Mayo Clinic Jacksonville
      • Miami, Florida, Estados Unidos
        • University of Miami Center for Liver Diseases
      • Sarasota, Florida, Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, Estados Unidos
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Estados Unidos
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos
        • Digestive and Liver Disease Clinic
    • Maine
      • Portland, Maine, Estados Unidos
        • Virology Treatment Center, Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Estados Unidos
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos
        • Beth Israel Deaconess Medical Center
      • Worcester, Massachusetts, Estados Unidos
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, Estados Unidos
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, Estados Unidos
        • St Louis University
    • Nebraska
      • Omaha, Nebraska, Estados Unidos
        • The Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos
        • University of New Mexico
    • New York
      • Manhasset, New York, Estados Unidos
        • North Shore University Hospital
      • New York, New York, Estados Unidos
    • North Carolina
      • Durham, North Carolina, Estados Unidos
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
        • University of Cincinnati
      • Cleveland, Ohio, Estados Unidos
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos
        • Penn State Hershey Medical Center
      • Pittsburgh, Pennsylvania, Estados Unidos
        • University of Pittsburgh Medical Center
    • South Carolina
      • Columbia, South Carolina, Estados Unidos
        • Columbia Gastroenterology Associates, PA
    • Tennessee
      • Germantown, Tennessee, Estados Unidos
        • Memphis Gastroenterology Group
    • Texas
      • Dallas, Texas, Estados Unidos
        • Liver Institute at Methodist Dallas
      • Houston, Texas, Estados Unidos
      • San Antonio, Texas, Estados Unidos
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, Estados Unidos
      • Charlottesville, Virginia, Estados Unidos
        • University of Virginia Health Systems
      • Fairfax, Virginia, Estados Unidos
        • Metropolitan Research
      • Richmond, Virginia, Estados Unidos
        • McGuire DVAMC
  • Francia
      • Creteil, Francia
        • Hospital Henri Mondor
      • Lyon, Francia
      • Nice, Francia
      • Paris, Francia
      • Pessac, Francia
      • Vandoeuvre, Francia
  • Países Bajos
      • Amsterdam, Países Bajos
        • Academic Medical Center
      • Leiden, Países Bajos
        • Leiden University Medical Center
      • Rotterdam, Países Bajos
        • Erasmus MC Medical Center
  • Puerto Rico
      • Santurce, Puerto Rico
        • Fundacion de Investigation de Diego
  • Reino Unido
      • London, Reino Unido

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 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

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

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
Droga: Ribavirina
Tableta
Droga: Telaprevir
Tableta
Otros nombres:
  • VX-950
Droga: Pegylated interferon alfa 2a
Solution for Injection
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Droga: Ribavirina
Tableta
Droga: Telaprevir
Tableta
Otros nombres:
  • VX-950
Droga: Pegylated interferon alfa 2a
Solution for Injection
Experimental: Other
Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Droga: Ribavirina
Tableta
Droga: Telaprevir
Tableta
Otros nombres:
  • VX-950
Droga: Pegylated interferon alfa 2a
Solution for Injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Periodo de tiempo: 24 weeks after the completion of treatment (up to Week 72)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
24 weeks after the completion of treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline through Week 48
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline through Week 48

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Prior Relapsers With Undetectable HCV RNA
Periodo de tiempo: 24 weeks after the completion of treatment (up to Week 72)
Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
Periodo de tiempo: End of treatment (up to Week 48)
Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
Periodo de tiempo: 48 weeks after completion of treatment (up to Week 96)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Periodo de tiempo: Baseline up to Week 72
Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Baseline up to Week 72

Colaboradores e Investigadores

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

Patrocinador

Vertex Pharmaceuticals Incorporated

Colaboradores

Tibotec, Inc

Investigadores

  • Director de estudio: Nathalie Adda, MD, Vertex Pharmaceuticals Incorporated

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 octubre de 2007

Finalización primaria (Actual)

1 de febrero de 2010

Finalización del estudio (Actual)

1 de febrero de 2010

Fechas de registro del estudio

Enviado por primera vez

25 de septiembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

25 de septiembre de 2007

Publicado por primera vez (Estimar)

26 de septiembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de agosto de 2014

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

9 de julio de 2014

Última verificación

1 de julio de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • VX06-950-107

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

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in United States

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir