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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adefovir Dipivoxil (ADV) | Experimental |
| |
| Lamivudine (LAM) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAM group | Drug | Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 52 |
| Time to Onset of HBV DNA Loss (< 400 Copies/mL) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adefovir (ADV) | ADV 10 mg orally once daily for 52 weeks |
| FG001 | Lamivudine (LAM) | LAM 100 mg orally once daily for 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adefovir (ADV) | ADV 10 mg orally once daily for 52 weeks |
| BG001 | Lamivudine (LAM) | LAM 100 mg orally once daily for 52 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per Protocol Set (PPS): participants in the Full Analysis Set (all subjects who entered the study, received at least one dose of investigational product, and had at least one efficacy assessment after the treatment initiation) population with no major protocol violations | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline and Week 52 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adefovir (ADV) | ADV 10 mg orally once daily for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| C106812 | adefovir dipivoxil |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| ADV group | Drug | Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily. |
|
|
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 | 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 | 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 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 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 | 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 | 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 | Summary statistics were displayed for serum ALT. | Week 52 |
| 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 | Week 52 |
| Time to Onset of ALT Normalization | 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 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Number of participants |
|
| Region of Enrollment | Number | participants |
|
LAM 100 mg orally once daily for 52 weeks
|
|
|
| Secondary | 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 | PPS | Posted | Number | Percentage of participants | Week 52 |
|
|
|
| Secondary | 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 | Not Posted | Median | 95% Confidence Interval | weeks | From Baseline to Week 52 |
| Secondary | 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 | PPS: participants who were positive for HBeAg at baseline | Posted | Number | percentage of participants | Week 52 |
|
|
|
| Secondary | 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 | PPS: participants who were positive for HBeAg and negative for HBeAb at baseline | Posted | Number | Percentage of participants | Week 52 |
|
|
|
| Secondary | 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. | Not Posted | Median | 95% Confidence Interval | weeks | From Baseline to Week 52 |
| Secondary | 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. | Not Posted | Median | 95% Confidence Interval | weeks | From Baseline to Week 52 |
| Secondary | 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 | PPS: participants who were positive for HBsAg at baseline | Posted | Number | percentage of participants | Week 52 |
|
|
|
| Secondary | 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 | PPS: participants who were positive for HBsAg and negative for HBsAb at baseline | Posted | Number | percentage of participants | Week 52 |
|
|
|
| Secondary | Mean Alanine Aminotransferase (ALT) Level at Week 52 | Summary statistics were displayed for serum ALT. | PPS | Posted | Mean | Standard Deviation | Units per Liter | Week 52 |
|
|
|
| Secondary | 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 | PPS: Participants with an abnormal ALT value (>ULN) at baseline | Posted | Number | Percentage of participants | Week 52 |
|
|
|
| Secondary | Time to Onset of ALT Normalization | Time to onset of ALT normalization was summarized using the Kaplan-Meier method. | PPS: Participants with abnormal ALT value (>ULN) at baseline | Posted | Median | 95% Confidence Interval | Week 52 | From Baseline to Week 52 |
|
|
|
| Secondary | 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 | PPS | Posted | Number | Percentage of participants | Week 52 |
|
|
|
| 0 |
| 52 |
| 39 |
| 52 |
| EG001 | Lamivudine (LAM) | LAM 100 mg orally once daily for 52 weeks | 4 | 53 | 47 | 53 |
| Pneumonia bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract inflammation | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |