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The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.
This study is a multicenter, randomized, active comparator-controlled, double-blind, parallel-group comparison study in Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue and its subsequent open-label study. Efficacy and safety will be compared between once-daily dosing of GSK548470 300 mg and once-daily dosing of ETV 0.5 mg, and subsequently the efficacy and safety of GSK548470 administered long term will be investigated. A total of 165 subjects will be assigned to the GSK548470 group or the ETV group at a ratio of 2:1. The subjects will be assigned by stratified randomization in terms of HBe antigen and serum HBV-DNA level. The primary purpose is to verify the non-inferiority of GSK548470 to ETV using as an index the change amount of HBV-DNA level at Week 24 from the baseline level. The secondary purpose is to investigate the efficacy and safety of GSK548470 300 mg administered once daily for a long term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK548470 300 mg | Experimental | GSK548470 300 mg tablet and ETV placebo capsule are administered once daily |
|
| ETV 0.5 mg | Active Comparator | ETV 0.5 mg capsule and GSK548470 placebo tablet are administered once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK548470 300 mg tablet | Drug | Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Serum HBV DNA Level at Week 24 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 466-8560 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28374496 | Derived | Koike K, Suyama K, Ito H, Itoh H, Sugiura W. Randomized prospective study showing the non-inferiority of tenofovir to entecavir in treatment-naive chronic hepatitis B patients. Hepatol Res. 2018 Jan;48(1):59-68. doi: 10.1111/hepr.12902. Epub 2017 May 24. |
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A total of 166 participants (110 participants in the Tenofovir Disoproxil Fumarate [GSK548470, TDF] group and 56 participants in the Entecavir Hydrate [ETV] group) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | TDF 300 mg OD | Participants received Tenofovir Disoproxil Fumarate (TDF) 300 milligrams (mg) tablet once daily (OD) and Entecavir Hydrate (ETV) placebo capsule OD for 96 weeks. |
| FG001 | ETV 0.5 mg OD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ETV 0.5 mg capsule | Drug | Brown capsules, each capsule containing 0.53 mg of entecavir hydrate |
|
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| Baseline, Week 48 and Week 96 |
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. | Week 24, Week 48 and Week 96 |
| Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values. | Week 24, Week 48 and Week 96 |
| Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values. | Week 24, Week 48 and Week 96 |
| Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values. | Week 24, Week 48 and Week 96 |
| Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values. | Week 24, Week 48 and Week 96 |
| Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values. | Week 24, Week 48 and Week 96 |
| Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values. | Baseline, Week 24, Week 48 and Week 96 |
| Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values. | Baseline, Week 24, Week 48 and Week 96 |
| Number of Participants With Virological Breakthrough Through End of the Study | The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit. | From Baseline to throughout study |
| Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered "Negative" in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit. | Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study) |
| Aichi |
| 467-8602 |
| Japan |
| GSK Investigational Site | Chiba | 260-8677 | Japan |
| GSK Investigational Site | Fukui | 918-8503 | Japan |
| GSK Investigational Site | Fukuoka | 803-8505 | Japan |
| GSK Investigational Site | Fukuoka | 810-8539 | Japan |
| GSK Investigational Site | Fukuoka | 812-8582 | Japan |
| GSK Investigational Site | Fukuoka | 820-8505 | Japan |
| GSK Investigational Site | Gifu | 500-8717 | Japan |
| GSK Investigational Site | Hiroshima | 734-8530 | Japan |
| GSK Investigational Site | Hyōgo | 651-2273 | Japan |
| GSK Investigational Site | Hyōgo | 663-8501 | Japan |
| GSK Investigational Site | Kagawa | 760-8557 | Japan |
| GSK Investigational Site | Kagoshima | 890-8520 | Japan |
| GSK Investigational Site | Kagoshima | 892-8512 | Japan |
| GSK Investigational Site | Kanagawa | 213-8587 | Japan |
| GSK Investigational Site | Kumamoto | 862-8655 | Japan |
| GSK Investigational Site | Miyagi | 980-8574 | Japan |
| GSK Investigational Site | Miyazaki | 880-0003 | Japan |
| GSK Investigational Site | Nagasaki | 852-8501 | Japan |
| GSK Investigational Site | Nagasaki | 856-8562 | Japan |
| GSK Investigational Site | Nara | 630-8305 | Japan |
| GSK Investigational Site | Okayama | 700-0913 | Japan |
| GSK Investigational Site | Okayama | 700-8511 | Japan |
| GSK Investigational Site | Osaka | 540-0006 | Japan |
| GSK Investigational Site | Osaka | 564-0013 | Japan |
| GSK Investigational Site | Saga | 840-8571 | Japan |
| GSK Investigational Site | Tokyo | 105-8470 | Japan |
| GSK Investigational Site | Tokyo | 105-8471 | Japan |
| GSK Investigational Site | Tokyo | 140-8522 | Japan |
| GSK Investigational Site | Tokyo | 162-8655 | Japan |
| GSK Investigational Site | Tokyo | 180-8610 | Japan |
Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TDF 300 mg OD | Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks. |
| BG001 | ETV 0.5 mg OD | Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics are presented for the full analysis set, which is defined as all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Baseline characteristics are presented for the full analysis set, which is defined as all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Baseline characteristics are presented for the full analysis set, which is defined as all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation. | Number | Participants |
|
| 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 Serum HBV DNA Level at Week 24 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | Standard Error | log10 copies/milliliter (copies/mL) | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96 | The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values. | Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 48 and Week 96 |
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| Secondary | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96 | The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. | FAS Population | Posted | Number | Participants | Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96 | The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values. | Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline. | Posted | Number | Participants | Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96 | The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values. | FAS Population. Only participants with positive HBeAg at Baseline were analyzed. | Posted | Number | Participants | Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values. | FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed. | Posted | Number | Participants | Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96 | The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values. | FAS Population. | Posted | Number | Participants | Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values. | FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed. | Posted | Number | Participants | Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values. | FAS Population | Posted | Number | Participants | Baseline, Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values. | FAS Population | Posted | Number | Participants | Baseline, Week 24, Week 48 and Week 96 |
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| Secondary | Number of Participants With Virological Breakthrough Through End of the Study | The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit. | FAS Population | Posted | Number | Participants | From Baseline to throughout study |
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| Secondary | Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study) | The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered "Negative" in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit. | FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Number | Participants | Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study) |
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Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
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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 | TDF 300 mg OD | Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks. | 7 | 109 | 83 | 109 | ||
| EG001 | ETV 0.5 mg OD | Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks. | 2 | 56 | 40 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
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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.
| 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D013607 | Tablets |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks. |
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