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

Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

13 de marzo de 2013 actualizado por: Bristol-Myers Squibb

A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study

The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

669

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

  • Argentina
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1282AEN
        • Local Institution
    • Prov De Santa
      • Rosario, Prov De Santa, Argentina, S2000PBJ
        • Local Institution
  • Australia
    • New South Wales
      • Westmead Nsw, New South Wales, Australia, 2145
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australia, 3168
        • Local Institution
      • Fitzroy, Victoria, Australia, 3065
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Prahan, Victoria, Australia, 3004
        • Local Institution
  • Brasil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30150
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre Rs, Rio Grande Do Sul, Brasil, 90035
        • Local Institution
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4Z6
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1H2
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3E 3P4
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canadá, M5G 2N2
        • Local Institution
      • Toronto, Ontario, Canadá, M5T 2S8
        • Local Institution
      • Toronto, Ontario, Canadá, M3N 2V7
        • Local Institution
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90017
        • Sergio E. Rojter
      • San Diego, California, Estados Unidos, 92105
        • Tuan Nguyen, Md
      • San Jose, California, Estados Unidos, 95128
        • San Jose Gastroenterology
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale University School of Medicine
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Atlanta Gastroenterology Associates
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21229
        • Digestive Disease Associates, P.A.
      • Laurel, Maryland, Estados Unidos, 20707
        • Maryland Digestive Disease Research, Llc
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan Health System
    • New York
      • Flushing, New York, Estados Unidos, 11355
        • Sing Chan, MD
      • Manhasset, New York, Estados Unidos, 11030
        • North Shore University
      • New York, New York, Estados Unidos, 10003
        • Beth Israel Medical Center
      • New York, New York, Estados Unidos, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Estados Unidos, 10016
        • Concorde Medical Group
  • Federación Rusa
      • Moscow, Federación Rusa, 105275
        • Local Institution
      • Moscow, Federación Rusa, 115446
        • Local Institution
      • Moscow, Federación Rusa, 117593
        • Local Institution
      • Smolensk, Federación Rusa, 214018
        • Local Institution
      • St. Petersburg, Federación Rusa, 194044
        • Local Institution
      • St. Petersburg, Federación Rusa, 190103
        • Local Institution
      • St. Petersburg, Federación Rusa, 191167
        • Local Institution
      • St. Petersburg, Federación Rusa, 191163
        • Local Institution
  • Francia
      • Grenoble Cedex 09, Francia, 38043
        • Local Institution
      • Marseille Cedex 08, Francia, 13285
        • Local Institution
      • Paris, Francia, 75014
        • Local Institution
      • Paris Cedex 12, Francia, 75571
        • Local Institution
      • Paris Cedex 13, Francia, 75013
        • Local Institution
      • Strasbourg, Francia, 67090
        • Local Institution
  • India
      • Lucknow, India, 226014
        • Local Institution
      • Ludhiana, India, 141001
        • Local Institution
      • Vellore, India, 632004
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Local Institution
  • Italia
      • Antella Firenze, Italia, 50012
        • Local Institution
      • Brescia, Italia, 25123
        • Local Institution
      • Pisa, Italia, 56124
        • Local Institution
      • Roma, Italia, 00149
        • Local Institution
  • México
      • Durango, México, 34229
        • Local Institution
  • Pavo
      • Bornova Izmir, Pavo, 35100
        • Local Institution
      • Cebeci Ankara, Pavo, 06620
        • Local Institution
      • Sihhiye Ankara, Pavo, 06100
        • Local Institution
      • Trabzon, Pavo, 61080
        • Local Institution
  • Polonia
      • Bialystok, Polonia, 15-540
        • Local Institution
      • Chorzow, Polonia, 41-500
        • Local Institution
      • Krakow, Polonia, 31-531
        • Local Institution
      • Lublin, Polonia, 20-081
        • Local Institution
      • Warszawa, Polonia, 01-201
        • Local Institution
  • Sudáfrica
    • Gauteng
      • Pretoria, Gauteng, Sudáfrica, 0001
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, Sudáfrica, 7530
        • Local Institution
      • N1 City Goodwood, Western Cape, Sudáfrica, 7463
        • 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

16 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or negative) disease
  • Nucleoside- and nucleotide-naive
  • Males or females ≥16 years of age (or minimum age of consent in a given country)
  • Compensated liver function
  • HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive participants
  • HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative participants
  • Alanine aminotransferase level ≥*upper limit of normal (ULN) and ≤10*ULN

Exclusion Criteria:

  • Evidence of decompensated cirrhosis
  • Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
  • Laboratory values out of protocol-specified range

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: TDF 0.5 mg
TDF=tenofovir
Droga: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Otros nombres:
  • Baraclude
  • BMS-200475
Experimental: ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
Droga: Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Otros nombres:
  • Baraclude
  • BMS-200475

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Periodo de tiempo: At Week 96
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Week 96

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status
Periodo de tiempo: At Weeks 48 and 96
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Weeks 48 and 96
Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Weeks 48 and 96
Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Weeks 48 and 96
Mean Log 10 HBV DNA at Weeks 48 and 96
Periodo de tiempo: Baseline, Weeks 48 and 96
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load.
Baseline, Weeks 48 and 96
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Weeks 48 and 96
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Weeks 48 and 96
Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.
At Weeks 48 and 96
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
At Weeks 48 and 96
Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.
At Weeks 48 and 96
Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
Periodo de tiempo: At Weeks 48 and 96
Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.
At Weeks 48 and 96
Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
Periodo de tiempo: From enrollment through Week 100 + 24-week follow-up
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.
From enrollment through Week 100 + 24-week follow-up
Number of Participants With HBV Resistance Through Week 48
Periodo de tiempo: Week 48
ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.
Week 48
Number of Participants With HBV Resistance at Week 96
Periodo de tiempo: Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.
Week 96
Number of Participants With Virologic Breakthrough at Week 48
Periodo de tiempo: Week 48
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir
Week 48
Number of Participants With Virologic Breakthrough at Week 96
Periodo de tiempo: Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
Week 96

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

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 abril de 2007

Finalización primaria (Actual)

1 de octubre de 2010

Finalización del estudio (Actual)

1 de octubre de 2010

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2006

Publicado por primera vez (Estimar)

12 de diciembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de marzo de 2013

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

13 de marzo de 2013

Última verificación

1 de marzo de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AI463-110

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 B Crónica

Ensayos clínicos sobre Entecavir

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Malaysia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir