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Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

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

A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

173

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

  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92037
        • Scripps Clinic
      • Los Angeles, California, Estados Unidos, 90057
        • National Research Institute
      • Los Angeles, California, Estados Unidos, 90036
        • Peter J Ruane Md Inc
      • Los Angeles, California, Estados Unidos, 90069
        • Anthony M. Mills Md Inc
      • Pasadena, California, Estados Unidos, 91105
        • Huntington Medical Research Institutes
      • San Diego, California, Estados Unidos, 92123
        • Medical Associates Research Group
      • San Diego, California, Estados Unidos, 92114
        • Precision Research Institute, LLC
      • San Francisco, California, Estados Unidos, 94115
        • Quest Clinical Research
    • Florida
      • Deland, Florida, Estados Unidos, 32720
        • Midland Florida Clinical Research Center, LLC
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida Hepatology Research
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Atlanta Gastroenterology Associates
      • Marietta, Georgia, Estados Unidos, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Downers Grove, Illinois, Estados Unidos, 60515
        • DuPage Medical Group
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21202
        • Mercy Medical Center, Inc.
      • Baltimore, Maryland, Estados Unidos, 21229
        • Digestive Disease Associates, P.A.
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64131
        • Kansas City Research Institute
    • New Mexico
      • Santa Fe, New Mexico, Estados Unidos, 87505
        • Southwest CARE Center
    • New York
      • Manhasset, New York, Estados Unidos, 11030
        • North Shore University Hospital
      • Poughkeepsie, New York, Estados Unidos, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Asheville Gastroenterology Associates, PA
      • Winston-salem, North Carolina, Estados Unidos, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Perkasie, Pennsylvania, Estados Unidos, 18944
        • Main Line Gastroenterology Associates Pc
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Center For Liver Diseases
    • Tennessee
      • Germantown, Tennessee, Estados Unidos, 38138
        • Gastro One
    • Texas
      • Arlington, Texas, Estados Unidos, 76012
        • Texas Clinical Research Institute, LLC
      • San Antonio, Texas, Estados Unidos, 78215
        • American Research Corporation
    • Utah
      • Murray, Utah, Estados Unidos, 84123
        • Clinical Research Centers Of America
      • Salt Lake City, Utah, Estados Unidos, 84106
        • Lifetree Clinical Research
    • Virginia
      • Falls Church, Virginia, Estados Unidos, 22042
        • INOVA Fairfax Hospital
    • Washington
      • Seattle, Washington, Estados Unidos, 98101
        • Virginia Mason Medical Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego

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

Descripción

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with hepatitis C virus (HCV) genotype 3
  • Subjects who are HCV treatment-naive
  • Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
  • HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

  • HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • 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 screening
  • Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

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: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Droga: Sofosbuvir
Droga: Daclatasvir
Otros nombres:
  • BMS-790052
Experimental: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Droga: Sofosbuvir
Droga: Daclatasvir
Otros nombres:
  • BMS-790052

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Periodo de tiempo: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12 (Follow-up period)
Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Periodo de tiempo: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12 (Follow-up period)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
Periodo de tiempo: Week 4
RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
Periodo de tiempo: Week 12
cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12
Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
Periodo de tiempo: Up to the end of treatment (up to 24 weeks)
EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Up to the end of treatment (up to 24 weeks)
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Periodo de tiempo: Week 1, 2, 6, 8 (treatment period)
Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 1, 2, 6, 8 (treatment period)
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Periodo de tiempo: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
Periodo de tiempo: Baseline, Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
Baseline, Week 12 (Follow-up period)
Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Periodo de tiempo: Week 12 (Follow-up period)
Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12 (Follow-up period)
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Periodo de tiempo: From Day 1 first dose to last dose plus 7 days
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.
From Day 1 first dose to last dose plus 7 days

Colaboradores e Investigadores

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

Patrocinador

Bristol-Myers Squibb

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 enero de 2014

Finalización primaria (Actual)

1 de septiembre de 2014

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

9 de enero de 2014

Primero enviado que cumplió con los criterios de control de calidad

9 de enero de 2014

Publicado por primera vez (Estimar)

10 de enero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de octubre de 2015

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

29 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

  • AI444-218

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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