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A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

23 de junio de 2016 actualizado por: Hoffmann-La Roche

A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

896

Fase

  • Fase 4

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

  • Argentina
      • Buenos Aires, Argentina, 1640
      • Buenos Aires, Argentina, C1282AFE
      • La Plata, Argentina, B1902AVF
      • Rosario, Argentina, 2000
  • Australia
      • Adelaide, Australia, 5000
      • Adelaide, Australia, 5042
      • Bankstown, Australia, 2200
      • Box Hill, Australia, 3128
      • Brisbane, Australia, 4029
      • Cottontree, Australia, 4558
      • Darlinghurst, Australia, 2010
      • Douglas, Australia
      • Fitzroy, Australia, 3065
      • Fremantle, Australia, 6160
      • Geelong, Australia, 3220
      • Greenslopes, Australia, 4120
      • Kingswood, Australia
      • Lismore, Australia, 2480
      • Liverpool, Australia, 1871
      • Liverpool, Australia, 2170
      • Melbourne, Australia, 3181
      • Melbourne, Australia, 3084
      • Melbourne, Australia, 3011
      • Melbourne, Australia, 3186
      • Miranda, Australia, 2228
      • Nedlands, Australia, 6009
      • New Lambton Heights, Australia, 2310
      • Parkville, Australia, 3052
      • Perth, Australia, 6001
      • Sydney, Australia, 2050
      • Sydney, Australia, 2145
      • Sydney, Australia, 2139
      • Sydney, Australia, 2010
      • Victoria, Australia, 3199
      • Woden, Australia, 2606
      • Wollongong, Australia, 2500
      • Woolloongabba, Australia, 4102
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N1
      • Edmonton, Alberta, Canadá, T5H 4B9
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
    • Ontario
      • Mississauga, Ontario, Canadá, L5M 2V8
    • Quebec
      • Montreal, Quebec, Canadá, H3T 1E2
  • México
      • Guadalajara, México, 44650
      • Guadalajara, México, 44280
      • Monterrey, México, 64460
  • Nueva Zelanda
      • Auckland, Nueva Zelanda, 100
      • Hamilton, Nueva Zelanda
      • Riccarton, Christchurch, Nueva Zelanda, 8011
  • Tailandia
      • Bangkok, Tailandia, 10400
      • Bangkok, Tailandia, 10700
      • Chiang Mai, Tailandia, 50202

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 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of chronic CHC, genotype 1
  • Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
  • Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
  • Compensated liver disease
  • Naive to interferon-based therapy for CHC infection

Exclusion Criteria:

  • Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
  • Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
  • Chronic liver disease other than CHC infection

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: PEG-IFN alfa-2a+Ribavirin - Induction Treatment
Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
Droga: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Otros nombres:
  • Pegasys
Droga: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Otros nombres:
  • Copegus
Experimental: PEG-IFN alfa-2a+Ribavirin - Standard Treatment
Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
Droga: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Otros nombres:
  • Pegasys
Droga: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Otros nombres:
  • Copegus

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
Periodo de tiempo: Week 72
Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.
Week 72

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Periodo de tiempo: Weeks 48
Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.
Weeks 48
Percentage of Participants With Virological Responses Over Time
Periodo de tiempo: Weeks 4, 8, 12, and 24
Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.
Weeks 4, 8, 12, and 24
Percentage of Participants With Relapse of End-of-treatment Virological Response
Periodo de tiempo: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.
Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
Periodo de tiempo: Weeks 4, 12, and 72
The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.
Weeks 4, 12, and 72
Change From Baseline in Log10 HCV RNA Values
Periodo de tiempo: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.
Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)

Colaboradores e Investigadores

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

Patrocinador

Hoffmann-La Roche

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 agosto de 2004

Finalización primaria (Actual)

1 de marzo de 2009

Finalización del estudio (Actual)

1 de marzo de 2009

Fechas de registro del estudio

Enviado por primera vez

13 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2005

Publicado por primera vez (Estimar)

19 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de agosto de 2016

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

23 de junio de 2016

Última verificación

1 de junio de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML17908

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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