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Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
LAM group
ADV group
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring treatment naive, CHB, adefovir, monotherapy

Eligibility Criteria

16 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Have compensated chronic hepatitis B. Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted. Ability to read, understand, and sign the informed consent. Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L Exclusion criteria: Having or suspected of having liver cancer. Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV). Autoimmune hepatitis. Received any previous transplantation or having a plan for any transplantation. Existence of any serious complication, except hepatitis B.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Adefovir Dipivoxil (ADV)

    Lamivudine (LAM)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
    Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52

    Secondary Outcome Measures

    Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52
    The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52
    Time to Onset of HBV DNA Loss (< 400 Copies/mL)
    Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0
    Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52
    Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method
    Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52
    Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method
    Time to Onset of HBeAg Loss
    Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.
    Time to Onset of HBeAg/Ab Seroconversion
    Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.
    Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52
    Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method
    Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52
    Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method
    Mean Alanine Aminotransferase (ALT) Level at Week 52
    Summary statistics were displayed for serum ALT.
    Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52
    ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline
    Time to Onset of ALT Normalization
    Time to onset of ALT normalization was summarized using the Kaplan-Meier method.
    Rate of Emergence of Resistant Virus at Week 52
    Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene

    Full Information

    First Posted
    April 19, 2006
    Last Updated
    October 1, 2009
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00316719
    Brief Title
    Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
    Official Title
    Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis B
    Keywords
    treatment naive, CHB, adefovir, monotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adefovir Dipivoxil (ADV)
    Arm Type
    Experimental
    Arm Title
    Lamivudine (LAM)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    LAM group
    Other Intervention Name(s)
    Lamivudine
    Intervention Description
    Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    ADV group
    Other Intervention Name(s)
    adefovir dipivoxil
    Intervention Description
    Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
    Description
    Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52
    Time Frame
    Baseline and Week 52
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52
    Description
    The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52
    Time Frame
    Week 52
    Title
    Time to Onset of HBV DNA Loss (< 400 Copies/mL)
    Description
    Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0
    Time Frame
    From Baseline to Week 52
    Title
    Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52
    Description
    Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method
    Time Frame
    Week 52
    Title
    Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52
    Description
    Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method
    Time Frame
    Week 52
    Title
    Time to Onset of HBeAg Loss
    Description
    Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.
    Time Frame
    From Baseline to Week 52
    Title
    Time to Onset of HBeAg/Ab Seroconversion
    Description
    Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.
    Time Frame
    From Baseline to Week 52
    Title
    Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52
    Description
    Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method
    Time Frame
    Week 52
    Title
    Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52
    Description
    Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method
    Time Frame
    Week 52
    Title
    Mean Alanine Aminotransferase (ALT) Level at Week 52
    Description
    Summary statistics were displayed for serum ALT.
    Time Frame
    Week 52
    Title
    Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52
    Description
    ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline
    Time Frame
    Week 52
    Title
    Time to Onset of ALT Normalization
    Description
    Time to onset of ALT normalization was summarized using the Kaplan-Meier method.
    Time Frame
    From Baseline to Week 52
    Title
    Rate of Emergence of Resistant Virus at Week 52
    Description
    Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene
    Time Frame
    Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Have compensated chronic hepatitis B. Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted. Ability to read, understand, and sign the informed consent. Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L Exclusion criteria: Having or suspected of having liver cancer. Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV). Autoimmune hepatitis. Received any previous transplantation or having a plan for any transplantation. Existence of any serious complication, except hepatitis B.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

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