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

13. März 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

669

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentinien, C1121ABE
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentinien, C1181ACH
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentinien, C1282AEN
        • Local Institution
    • Prov De Santa
      • Rosario, Prov De Santa, Argentinien, 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
  • Frankreich
      • Grenoble Cedex 09, Frankreich, 38043
        • Local Institution
      • Marseille Cedex 08, Frankreich, 13285
        • Local Institution
      • Paris, Frankreich, 75014
        • Local Institution
      • Paris Cedex 12, Frankreich, 75571
        • Local Institution
      • Paris Cedex 13, Frankreich, 75013
        • Local Institution
      • Strasbourg, Frankreich, 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
  • 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
  • Mexiko
      • Durango, Mexiko, 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
  • Russische Föderation
      • Moscow, Russische Föderation, 105275
        • Local Institution
      • Moscow, Russische Föderation, 115446
        • Local Institution
      • Moscow, Russische Föderation, 117593
        • Local Institution
      • Smolensk, Russische Föderation, 214018
        • Local Institution
      • St. Petersburg, Russische Föderation, 194044
        • Local Institution
      • St. Petersburg, Russische Föderation, 190103
        • Local Institution
      • St. Petersburg, Russische Föderation, 191167
        • Local Institution
      • St. Petersburg, Russische Föderation, 191163
        • Local Institution
  • Südafrika
    • Gauteng
      • Pretoria, Gauteng, Südafrika, 0001
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, Südafrika, 7530
        • Local Institution
      • N1 City Goodwood, Western Cape, Südafrika, 7463
        • Local Institution
  • Truthahn
      • Bornova Izmir, Truthahn, 35100
        • Local Institution
      • Cebeci Ankara, Truthahn, 06620
        • Local Institution
      • Sihhiye Ankara, Truthahn, 06100
        • Local Institution
      • Trabzon, Truthahn, 61080
        • Local Institution
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90017
        • Sergio E. Rojter
      • San Diego, California, Vereinigte Staaten, 92105
        • Tuan Nguyen, Md
      • San Jose, California, Vereinigte Staaten, 95128
        • San Jose Gastroenterology
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06510
        • Yale University School Of Medicine
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • Atlanta Gastroenterology Associates
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21229
        • Digestive Disease Associates, P.A.
      • Laurel, Maryland, Vereinigte Staaten, 20707
        • Maryland Digestive Disease Research, Llc
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan Health System
    • New York
      • Flushing, New York, Vereinigte Staaten, 11355
        • Sing Chan, MD
      • Manhasset, New York, Vereinigte Staaten, 11030
        • North Shore University
      • New York, New York, Vereinigte Staaten, 10003
        • Beth Israel Medical Center
      • New York, New York, Vereinigte Staaten, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Vereinigte Staaten, 10016
        • Concorde Medical Group

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: TDF 0.5 mg
TDF=tenofovir
Arzneimittel: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Andere Namen:
  • Baraklude
  • BMS-200475
Experimental: ETV 0.5 mg +TDF 300 mg
ETV=entecavir; TDF=tenofovir
Arzneimittel: Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Andere Namen:
  • Baraklude
  • BMS-200475

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
Week 96

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2007

Primärer Abschluss (Tatsächlich)

1. Oktober 2010

Studienabschluss (Tatsächlich)

1. Oktober 2010

Studienanmeldedaten

Zuerst eingereicht

11. Dezember 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Dezember 2006

Zuerst gepostet (Schätzen)

12. Dezember 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. März 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. März 2013

Zuletzt verifiziert

1. März 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AI463-110

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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