Skip to main content
OpenTrials
Completed

NCT Number: NCT00316719

Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LAM group

Drug

Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.

Other names: Lamivudine

ADV group

Drug

Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.

Other names: adefovir dipivoxil

Primary outcomes

  1. Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52

    Time frame: Baseline and 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 outcomes

  1. Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52

    Time frame: 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

  2. Time to Onset of HBV DNA Loss (< 400 Copies/mL)

    Time frame: From Baseline to Week 52

    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

  3. Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52

    Time frame: Week 52

    Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method

  4. Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52

    Time frame: 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

  5. Time to Onset of HBeAg Loss

    Time frame: From Baseline to Week 52

    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.

  6. Time to Onset of HBeAg/Ab Seroconversion

    Time frame: From Baseline to Week 52

    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.

  7. Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52

    Time frame: Week 52

    Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method

  8. Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52

    Time frame: 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

  9. Mean Alanine Aminotransferase (ALT) Level at Week 52

    Time frame: Week 52

    Summary statistics were displayed for serum ALT.

  10. Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52

    Time frame: 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

  11. Time to Onset of ALT Normalization

    Time frame: From Baseline to Week 52

    Time to onset of ALT normalization was summarized using the Kaplan-Meier method.

  12. Rate of Emergence of Resistant Virus at Week 52

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 21, 2006
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.