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

13 de março de 2013 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

669

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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
  • Austrália
    • New South Wales
      • Westmead Nsw, New South Wales, Austrália, 2145
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Austrália, 3168
        • Local Institution
      • Fitzroy, Victoria, Austrália, 3065
        • Local Institution
      • Heidelberg, Victoria, Austrália, 3084
        • Local Institution
      • Prahan, Victoria, Austrália, 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
  • Federação Russa
      • Moscow, Federação Russa, 105275
        • Local Institution
      • Moscow, Federação Russa, 115446
        • Local Institution
      • Moscow, Federação Russa, 117593
        • Local Institution
      • Smolensk, Federação Russa, 214018
        • Local Institution
      • St. Petersburg, Federação Russa, 194044
        • Local Institution
      • St. Petersburg, Federação Russa, 190103
        • Local Institution
      • St. Petersburg, Federação Russa, 191167
        • Local Institution
      • St. Petersburg, Federação Russa, 191163
        • Local Institution
  • França
      • Grenoble Cedex 09, França, 38043
        • Local Institution
      • Marseille Cedex 08, França, 13285
        • Local Institution
      • Paris, França, 75014
        • Local Institution
      • Paris Cedex 12, França, 75571
        • Local Institution
      • Paris Cedex 13, França, 75013
        • Local Institution
      • Strasbourg, França, 67090
        • Local Institution
  • Itália
      • Antella Firenze, Itália, 50012
        • Local Institution
      • Brescia, Itália, 25123
        • Local Institution
      • Pisa, Itália, 56124
        • Local Institution
      • Roma, Itália, 00149
        • Local Institution
  • México
      • Durango, México, 34229
        • Local Institution
  • Peru
      • Bornova Izmir, Peru, 35100
        • Local Institution
      • Cebeci Ankara, Peru, 06620
        • Local Institution
      • Sihhiye Ankara, Peru, 06100
        • Local Institution
      • Trabzon, Peru, 61080
        • Local Institution
  • Polônia
      • Bialystok, Polônia, 15-540
        • Local Institution
      • Chorzow, Polônia, 41-500
        • Local Institution
      • Krakow, Polônia, 31-531
        • Local Institution
      • Lublin, Polônia, 20-081
        • Local Institution
      • Warszawa, Polônia, 01-201
        • Local Institution
  • África do Sul
    • Gauteng
      • Pretoria, Gauteng, África do Sul, 0001
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, África do Sul, 7530
        • Local Institution
      • N1 City Goodwood, Western Cape, África do Sul, 7463
        • Local Institution
  • Índia
      • Lucknow, Índia, 226014
        • Local Institution
      • Ludhiana, Índia, 141001
        • Local Institution
      • Vellore, Índia, 632004
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Índia, 500082
        • Local Institution

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

16 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: TDF 0.5 mg
TDF=tenofovir
Medicamento: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Outros nomes:
  • Baraclude
  • BMS-200475
Experimental: ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
Medicamento: Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Outros nomes:
  • Baraclude
  • BMS-200475

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Bristol-Myers Squibb

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2007

Conclusão Primária (Real)

1 de outubro de 2010

Conclusão do estudo (Real)

1 de outubro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

11 de dezembro de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de dezembro de 2006

Primeira postagem (Estimativa)

12 de dezembro de 2006

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

15 de março de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de março de 2013

Última verificação

1 de março de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AI463-110

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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