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

13 marzo 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

669

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Brasile
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasile, 30150
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre Rs, Rio Grande Do Sul, Brasile, 90035
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Local Institution
      • Toronto, Ontario, Canada, M5T 2S8
        • Local Institution
      • Toronto, Ontario, Canada, M3N 2V7
        • Local Institution
  • Federazione Russa
      • Moscow, Federazione Russa, 105275
        • Local Institution
      • Moscow, Federazione Russa, 115446
        • Local Institution
      • Moscow, Federazione Russa, 117593
        • Local Institution
      • Smolensk, Federazione Russa, 214018
        • Local Institution
      • St. Petersburg, Federazione Russa, 194044
        • Local Institution
      • St. Petersburg, Federazione Russa, 190103
        • Local Institution
      • St. Petersburg, Federazione Russa, 191167
        • Local Institution
      • St. Petersburg, Federazione Russa, 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
  • Messico
      • Durango, Messico, 34229
        • 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
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90017
        • Sergio E. Rojter
      • San Diego, California, Stati Uniti, 92105
        • Tuan Nguyen, Md
      • San Jose, California, Stati Uniti, 95128
        • San Jose Gastroenterology
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06510
        • Yale University School of Medicine
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
        • Atlanta Gastroenterology Associates
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21229
        • Digestive Disease Associates, P.A.
      • Laurel, Maryland, Stati Uniti, 20707
        • Maryland Digestive Disease Research, Llc
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan Health System
    • New York
      • Flushing, New York, Stati Uniti, 11355
        • Sing Chan, MD
      • Manhasset, New York, Stati Uniti, 11030
        • North Shore University
      • New York, New York, Stati Uniti, 10003
        • Beth Israel Medical Center
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Stati Uniti, 10016
        • Concorde Medical Group
  • Sud Africa
    • Gauteng
      • Pretoria, Gauteng, Sud Africa, 0001
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, Sud Africa, 7530
        • Local Institution
      • N1 City Goodwood, Western Cape, Sud Africa, 7463
        • Local Institution
  • Tacchino
      • Bornova Izmir, Tacchino, 35100
        • Local Institution
      • Cebeci Ankara, Tacchino, 06620
        • Local Institution
      • Sihhiye Ankara, Tacchino, 06100
        • Local Institution
      • Trabzon, Tacchino, 61080
        • Local Institution

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TDF 0.5 mg
TDF=tenofovir
Droga: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Altri nomi:
  • Baraclude
  • BMS-200475
Sperimentale: 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
Altri nomi:
  • Baraclude
  • BMS-200475

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
Week 96

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2007

Completamento primario (Effettivo)

1 ottobre 2010

Completamento dello studio (Effettivo)

1 ottobre 2010

Date di iscrizione allo studio

Primo inviato

11 dicembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

11 dicembre 2006

Primo Inserito (Stima)

12 dicembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

15 marzo 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 marzo 2013

Ultimo verificato

1 marzo 2013

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI463-110

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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CROs by country

CROs in Italy

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

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