Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

Last updated: November 25, 2014
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT01063036
AI463-203
2009-015705-40
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-eantigen(HBeAg)-negative or HBeAg-positive

  • Subjects must have a treatment failure to their current nucleoside/ nucleotidetreatment regimen

  • Prior entecavir and/or tenofovir monotherapy is allowed

  • Subjects must have compensated liver function

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding

  • Evidence of decompensated cirrhosis

  • Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

  • Moderate or severe renal impairment

  • Recent history of pancreatitis

  • Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks ofbeing assigned to study drug into this study

  • Prior entecavir/tenofovir combination therapy

Study Design

Total Participants: 144
Study Start date:
May 01, 2010
Estimated Completion Date:
February 28, 2014

Connect with a study center

  • Local Institution

    Clichy, 92110
    France

    Site Not Available

  • Local Institution

    Lyons Cedex 04, 69317
    France

    Site Not Available

  • Local Institution

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Local Institution

    Orleans Cedex 2, 45067
    France

    Site Not Available

  • Local Institution

    Strasbourg, 67000
    France

    Site Not Available

  • Local Institution

    Berlin, 10969
    Germany

    Site Not Available

  • Local Institution

    Frankfurt, 60590
    Germany

    Site Not Available

  • Local Institution

    Hamburg, 20246
    Germany

    Site Not Available

  • Local Institution

    Hannover, 30625
    Germany

    Site Not Available

  • Local Institution

    Heindelberg, 69120
    Germany

    Site Not Available

  • Local Institution

    Mainz, 55131
    Germany

    Site Not Available

  • Local Institution

    Munchen, 81675
    Germany

    Site Not Available

  • Local Institution

    Tubingen, 72076
    Germany

    Site Not Available

  • Local Institution

    Bagno A Ripoli (Fi), 50012
    Italy

    Site Not Available

  • Local Institution

    Bari, 70124
    Italy

    Site Not Available

  • Local Institution

    Foggia, 71100
    Italy

    Site Not Available

  • Local Institution

    Milano, 20122
    Italy

    Site Not Available

  • Local Institution

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Local Institution

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Local Institution

    Leiden, 2300 RC
    Netherlands

    Site Not Available

  • Local Institution

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • Local Institution

    Kielce, 25-317
    Poland

    Site Not Available

  • Local Institution

    Krakow, 31-531
    Poland

    Site Not Available

  • Local Institution

    Lodz, 91-347
    Poland

    Site Not Available

  • Local Institution

    Wroclaw, 50-349
    Poland

    Site Not Available

  • Local Institution

    Bucuresti, 021105
    Romania

    Site Not Available

  • Local Institution

    Burcuresti, 022328
    Romania

    Site Not Available

  • Local Institution

    Timisoara, 300 002
    Romania

    Site Not Available

  • Local Institution

    Barcelona, 08025
    Spain

    Site Not Available

  • Local Institution

    Valencia, 46014
    Spain

    Site Not Available

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