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VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

14 de mayo de 2014 actualizado por: Janssen Infectious Diseases BVBA

A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Tipo de estudio

Intervencionista

Inscripción (Actual)

744

Fase

  • Fase 3

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
      • Bochum, Alemania
      • Essen, Alemania
      • Frankfurt, Alemania
      • Hamburg, Alemania
      • Kiel, Alemania
      • Mainz, Alemania
      • Regensburg, Alemania
  • Australia
      • Adelaide, Australia
      • Camperdown, Australia
      • Clayton, Australia
      • Darlinghurst, Australia
      • Fitzroy, Australia
      • Greenslopes, Australia
      • Melbourne, Australia
      • Perth, Australia
  • Austria
      • Graz N/A, Austria
      • Linz, Austria
      • Wien, Austria
  • Brasil
      • Campinas, Brasil
      • Salvador, Brasil
      • Santo Andre, Brasil
      • Sao Paulo, Brasil
      • São Paulo, Brasil
  • Bélgica
      • Antwerpen, Bélgica
      • Brussels, Bélgica
      • Genk, Bélgica
      • Gent, Bélgica
      • Leuven, Bélgica
      • Liege, Bélgica
  • España
      • Barcelona, España
      • Barcelona N/A, España
      • Madrid, España
      • Malaga N/A, España
      • Santander N/A, España
      • Sevilla N/A, España
      • Valencia, España
  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos
      • Los Angeles, California, Estados Unidos
      • San Diego, California, Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos
    • Connecticut
      • New Haven, Connecticut, Estados Unidos
    • Florida
      • Bradenton, Florida, Estados Unidos
      • Jacksonville, Florida, Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos
      • Marietta, Georgia, Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos
      • Downers Grove, Illinois, Estados Unidos
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos
    • Maryland
      • Lutherville, Maryland, Estados Unidos
    • Missouri
      • Kansas City, Missouri, Estados Unidos
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos
    • New Jersey
      • Egg Harbor Twp, New Jersey, Estados Unidos
    • New Mexico
      • Santa Fe, New Mexico, Estados Unidos
    • New York
      • New York, New York, Estados Unidos
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos
      • Durham, North Carolina, Estados Unidos
      • Statesville, North Carolina, Estados Unidos
      • Winston Salem, North Carolina, Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos
      • Hershey, Pennsylvania, Estados Unidos
      • Philadelphia, Pennsylvania, Estados Unidos
      • Pittsburgh, Pennsylvania, Estados Unidos
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
      • Columbia, South Carolina, Estados Unidos
    • Texas
      • Arlington, Texas, Estados Unidos
      • Dallas, Texas, Estados Unidos
      • Houston, Texas, Estados Unidos
      • San Antonio, Texas, Estados Unidos
    • Virginia
      • Falls Church, Virginia, Estados Unidos
      • Norfolk, Virginia, Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos
  • Francia
      • Clichy, Francia
      • Creteil, Francia
      • Grenoble, Francia
      • Lille, Francia
      • Lyon, Francia
      • Paris, Francia
      • Pessac, Francia
      • Vandoeuvre Les Nancy, Francia
      • Villejuif Cedex, Francia
  • Irlanda
      • Dublin, Irlanda
      • Dublin 9, Irlanda
  • México
      • Mex Ctity, México
      • Mexico, México
      • Monterrey, México
  • Polonia
      • Bialystok, Polonia
      • Bydgoszcz, Polonia
      • Czeladz, Polonia
      • Kielce, Polonia
      • Krakow, Polonia
      • Warszawa, Polonia
  • Reino Unido
      • Birmingham, Reino Unido
      • Edinburgh, Reino Unido
      • Glasgow, Reino Unido
      • London, Reino Unido
      • Manchester, Reino Unido
  • Suecia
      • Göteborg, Suecia
      • Malmö, Suecia
      • Stockholm, Suecia

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:

  • Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
  • Patients should not have had any previous treatment for hepatitis C
  • Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
  • Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
  • A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

  • Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
  • Patient has a pre-existing psychiatric condition
  • Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Droga: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Droga: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
Experimental: 002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Droga: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Droga: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Droga: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Periodo de tiempo: End of trial, 12 weeks after last planned dose
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
End of trial, 12 weeks after last planned dose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Periodo de tiempo: End of trial, 24 weeks after last planned dose
The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
End of trial, 24 weeks after last planned dose
Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Periodo de tiempo: End of trial, 72 weeks after the start of study medication
The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
End of trial, 72 weeks after the start of study medication
Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Periodo de tiempo: Baseline, Week 4 and Week 4+12.
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
Baseline, Week 4 and Week 4+12.
Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Periodo de tiempo: Week 4, 12, 24, 32, 40
The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
Week 4, 12, 24, 32, 40
Percentage of Participants Who Relapsed During Follow-up Period
Periodo de tiempo: During Follow-Up (24 weeks after the last dose of study drug)
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
During Follow-Up (24 weeks after the last dose of study drug)
Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Periodo de tiempo: End of trial, 12 weeks after the last planned dose
The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
End of trial, 12 weeks after the last planned dose

Colaboradores e Investigadores

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

Patrocinador

Janssen Infectious Diseases BVBA

Colaboradores

Vertex Pharmaceuticals Incorporated

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.

Publicaciones Generales

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 diciembre de 2010

Finalización primaria (Actual)

1 de agosto de 2012

Finalización del estudio (Actual)

1 de noviembre de 2012

Fechas de registro del estudio

Enviado por primera vez

28 de octubre de 2010

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2010

Publicado por primera vez (Estimar)

16 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de junio de 2014

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

14 de mayo de 2014

Última verificación

1 de mayo de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR013711
  • OPTIMIZE-HCV (Otro identificador: Janssen Infectious Diseases BVBA)
  • VX-950-C211 (Otro identificador: Janssen Infectious Diseases BVBA)
  • 2010-021628-84 (Número EudraCT)

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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