Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

October 1, 2009 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adefovir Dipivoxil (ADV)
Drug: ADV group
Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Other Names:
  • adefovir dipivoxil
Active Comparator: Lamivudine (LAM)
Drug: LAM group
Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
Other Names:
  • Lamivudine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 52
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
From Baseline to Week 52
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
Week 52
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
Week 52
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.
From Baseline to Week 52
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.
From Baseline to Week 52
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
Week 52
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
Week 52
Mean Alanine Aminotransferase (ALT) Level at Week 52
Time Frame: Week 52
Summary statistics were displayed for serum ALT.
Week 52
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
Week 52
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.
From Baseline to Week 52
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
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 19, 2006

First Submitted That Met QC Criteria

April 19, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADF105220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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