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Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

23 de septiembre de 2015 actualizado por: Bristol-Myers Squibb

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

350

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

  • Estados Unidos
    • California
      • Coronado, California, Estados Unidos, 92118
        • Southern California Liver Centers
      • San Diego, California, Estados Unidos, 92105
        • Research and Education, Inc.
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University Of Colorado Denver & Hospital
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University Of Florida Hepatology
      • Orlando, Florida, Estados Unidos, 32803
        • Orlando Immunology Center
      • South Miami, Florida, Estados Unidos, 33143
        • Miami Research Associates
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21202
        • Mercy Medical Center
      • Lutherville, Maryland, Estados Unidos, 21093
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan Health System
    • New York
      • Bronx, New York, Estados Unidos, 10468
        • Bronx Va Medical Center 3c Sub-J
      • New York, New York, Estados Unidos, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, Estados Unidos, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, Estados Unidos, 78215
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, Estados Unidos, 22003
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53715
        • Dean Clinic
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • 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 a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Men and women, ages 18 to 70 years.
  • Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
  • Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV.
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
  • History of hemophilia.
  • History of torsade de pointes.
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
  • History of gastrointestinal disease or surgical procedure (except cholecystectomy).
  • History of clinically significant cardiac disease.
  • Blood transfusion within 4 weeks prior to study drug administration.
  • Poor venous access.
  • Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

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: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Experimental: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Experimental: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Experimental: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Experimental: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Otros nombres:
  • Copegus ®
Experimental: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Otros nombres:
  • Copegus ®
Experimental: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Experimental: Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Otros nombres:
  • Copegus ®
Experimental: Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Experimental: Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Droga: PSI-7977
Tablets, oral, 400 mg, once daily
Droga: Daclatasvir
Tablets, oral, 60 mg, once daily
Otros nombres:
  • BMS-790052
Droga: Ribavirin
Tablets, oral, 200 mg
Otros nombres:
  • Copegus ®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Periodo de tiempo: Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Periodo de tiempo: Follow-up Week 24
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
Periodo de tiempo: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Periodo de tiempo: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Periodo de tiempo: Baseline, Follow-up week 24
Change from baseline in log10 HCV RNA at scheduled sampling time.
Baseline, Follow-up week 24
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Periodo de tiempo: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Periodo de tiempo: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

Colaboradores e Investigadores

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

Patrocinador

Bristol-Myers Squibb

Colaboradores

Pharmasset

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

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 junio de 2011

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de octubre de 2013

Fechas de registro del estudio

Enviado por primera vez

23 de mayo de 2011

Primero enviado que cumplió con los criterios de control de calidad

24 de mayo de 2011

Publicado por primera vez (Estimar)

25 de mayo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de octubre de 2015

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

23 de septiembre de 2015

Última verificación

1 de septiembre de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AI444-040

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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