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

13. marts 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

669

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
    • New South Wales
      • Westmead Nsw, New South Wales, Australien, 2145
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australien, 3168
        • Local Institution
      • Fitzroy, Victoria, Australien, 3065
        • Local Institution
      • Heidelberg, Victoria, Australien, 3084
        • Local Institution
      • Prahan, Victoria, Australien, 3004
        • Local Institution
  • Brasilien
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30150
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre Rs, Rio Grande Do Sul, Brasilien, 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
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 105275
        • Local Institution
      • Moscow, Den Russiske Føderation, 115446
        • Local Institution
      • Moscow, Den Russiske Føderation, 117593
        • Local Institution
      • Smolensk, Den Russiske Føderation, 214018
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 194044
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 190103
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 191167
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 191163
        • Local Institution
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90017
        • Sergio E. Rojter
      • San Diego, California, Forenede Stater, 92105
        • Tuan Nguyen, Md
      • San Jose, California, Forenede Stater, 95128
        • San Jose Gastroenterology
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale University School of Medicine
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Atlanta Gastroenterology Associates
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
        • Digestive Disease Associates, P.A.
      • Laurel, Maryland, Forenede Stater, 20707
        • Maryland Digestive Disease Research, Llc
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Health System
    • New York
      • Flushing, New York, Forenede Stater, 11355
        • Sing Chan, MD
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Medical Center
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Forenede Stater, 10016
        • Concorde Medical Group
  • Frankrig
      • Grenoble Cedex 09, Frankrig, 38043
        • Local Institution
      • Marseille Cedex 08, Frankrig, 13285
        • Local Institution
      • Paris, Frankrig, 75014
        • Local Institution
      • Paris Cedex 12, Frankrig, 75571
        • Local Institution
      • Paris Cedex 13, Frankrig, 75013
        • Local Institution
      • Strasbourg, Frankrig, 67090
        • Local Institution
  • Indien
      • Lucknow, Indien, 226014
        • Local Institution
      • Ludhiana, Indien, 141001
        • Local Institution
      • Vellore, Indien, 632004
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien, 500082
        • Local Institution
  • Italien
      • Antella Firenze, Italien, 50012
        • Local Institution
      • Brescia, Italien, 25123
        • Local Institution
      • Pisa, Italien, 56124
        • Local Institution
      • Roma, Italien, 00149
        • Local Institution
  • Kalkun
      • Bornova Izmir, Kalkun, 35100
        • Local Institution
      • Cebeci Ankara, Kalkun, 06620
        • Local Institution
      • Sihhiye Ankara, Kalkun, 06100
        • Local Institution
      • Trabzon, Kalkun, 61080
        • Local Institution
  • Mexico
      • Durango, Mexico, 34229
        • Local Institution
  • Polen
      • Bialystok, Polen, 15-540
        • Local Institution
      • Chorzow, Polen, 41-500
        • Local Institution
      • Krakow, Polen, 31-531
        • Local Institution
      • Lublin, Polen, 20-081
        • Local Institution
      • Warszawa, Polen, 01-201
        • Local Institution
  • Sydafrika
    • Gauteng
      • Pretoria, Gauteng, Sydafrika, 0001
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, Sydafrika, 7530
        • Local Institution
      • N1 City Goodwood, Western Cape, Sydafrika, 7463
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TDF 0.5 mg
TDF=tenofovir
Medicin: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Andre navne:
  • Baraclude
  • BMS-200475
Eksperimentel: ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
Medicin: Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Andre navne:
  • Baraclude
  • BMS-200475

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
Week 96

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2007

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

11. december 2006

Først indsendt, der opfyldte QC-kriterier

11. december 2006

Først opslået (Skøn)

12. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI463-110

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis B, kronisk

Kliniske forsøg med Entecavir

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner