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Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Primary Purpose

Hepatitis B, Chronic

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lamivudine
Entecavir
Adefovir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
  • Naïve to nucleoside/nucleotide analogues except for LVD
  • HBV DNA > 17,200 IU/mL
  • Compensated liver function
  • Serum ALT <10 × ULN

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Evidence of decompensated cirrhosis
  • Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Lamivudine plus Adefovir

    Entecavir

    Entecavir plus Adefovir

    Arm Description

    Outcomes

    Primary Outcome Measures

    The proportion of patients with HBV DNA < 50 IU/mL at W48

    Secondary Outcome Measures

    The proportion of patient with HBV DNA < 50 IU/mL at W 96
    Mean reduction of HBV DNA at W 48 & 96
    The proportion of subjects with ALT normalization at W 48 & 96
    The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96
    Safety
    Resistance

    Full Information

    First Posted
    September 29, 2009
    Last Updated
    August 31, 2015
    Sponsor
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00986778
    Brief Title
    Entecavir Plus Adefovir in Lamivudine-Resistant Patients
    Official Title
    A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business Objectives Changed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    June 2014 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bristol-Myers Squibb

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lamivudine plus Adefovir
    Arm Type
    Active Comparator
    Arm Title
    Entecavir
    Arm Type
    Active Comparator
    Arm Title
    Entecavir plus Adefovir
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Lamivudine
    Other Intervention Name(s)
    Heptotin
    Intervention Description
    Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
    Intervention Type
    Drug
    Intervention Name(s)
    Entecavir
    Other Intervention Name(s)
    Baraclude
    Intervention Description
    Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
    Intervention Type
    Drug
    Intervention Name(s)
    Adefovir
    Other Intervention Name(s)
    Hepsera
    Intervention Description
    Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
    Primary Outcome Measure Information:
    Title
    The proportion of patients with HBV DNA < 50 IU/mL at W48
    Time Frame
    Week 48
    Secondary Outcome Measure Information:
    Title
    The proportion of patient with HBV DNA < 50 IU/mL at W 96
    Time Frame
    Week 96
    Title
    Mean reduction of HBV DNA at W 48 & 96
    Time Frame
    Week 48 and 96
    Title
    The proportion of subjects with ALT normalization at W 48 & 96
    Time Frame
    Week 48 & Week 96
    Title
    The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96
    Time Frame
    Week 48 & 96
    Title
    Safety
    Time Frame
    Week 48 and Week 96
    Title
    Resistance
    Time Frame
    Week 48 & Week 96

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I Naïve to nucleoside/nucleotide analogues except for LVD HBV DNA > 17,200 IU/mL Compensated liver function Serum ALT <10 × ULN Exclusion Criteria: Women who are pregnant or breastfeeding Evidence of decompensated cirrhosis Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bristol-Myers Squibb
    Organizational Affiliation
    Bristol-Myers Squibb
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Entecavir Plus Adefovir in Lamivudine-Resistant Patients

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