Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

Phase 3

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: ADV group; Drug: LAM group

• Registration Number: NCT00316719
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-04-19
• Study First Submitted QC: 2006-04-19
• Study First Posted: 2006-04-21
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-06-15
• Results First Submitted QC: 2009-06-16
• Results First Posted: 2009-08-03
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adefovir Dipivoxil (ADV)	ADV group	-
Lamivudine (LAM)	LAM group	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52	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 Outcome Measures

Name	Time	Method
Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52	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)	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
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52	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	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	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.
Time to Onset of HBeAg/Ab Seroconversion	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.
Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52	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	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	Week 52	Summary statistics were displayed for serum ALT.
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52	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	From Baseline to Week 52	Time to onset of ALT normalization was summarized using the Kaplan-Meier method.
Rate of Emergence of Resistant Virus at Week 52	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