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

13. března 2013 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

669

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

16 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: TDF 0.5 mg
TDF=tenofovir
Lék: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Ostatní jména:
  • Baraclude
  • BMS-200475
Experimentální: ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
Lék: Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Ostatní jména:
  • Baraclude
  • BMS-200475

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
Week 96

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bristol-Myers Squibb

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2007

Primární dokončení (Aktuální)

1. října 2010

Dokončení studie (Aktuální)

1. října 2010

Termíny zápisu do studia

První předloženo

11. prosince 2006

První předloženo, které splnilo kritéria kontroly kvality

11. prosince 2006

První zveřejněno (Odhad)

12. prosince 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

15. března 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. března 2013

Naposledy ověřeno

1. března 2013

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AI463-110

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Hepatitida B, chronická

Klinické studie na Entecavir

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Tanzania

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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