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The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.
This is a multicenter, open-label study in Japanese patients with compensated chronic hepatitis B with poor response to other drugs in order to evaluate the efficacy and safety of GSK548470 administered at a dose of 300 mg once daily. The target sample size is set at 32 subjects. The primary objective is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in subjects with compensated chronic hepatitis B with poor response to other drugs. The secondary objective is to evaluate the long-term efficacy and safety of once-daily treatment with GSK548470 300 mg.To evaluate the efficacy and safety of GSK548470 in the study, subjects receiving a combination of lamivudine (LAM) and adefovir pivoxil (ADV) will be switched to a combination of LAM and GSK548470, while subjects on entecavir hydrate (ETV) with or without ADV will be switched to a combination of ETV and GSK548470.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK548470 300 mg | Experimental | GSK548470 300 mg tablet is administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK548470 300 mg tablet | Drug | Blue tablets containing 300 mg of tenofovir disoproxil fumarate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24 | The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level < the lower limit of quantitation (2.1 log10 copies/millilitres[copies/mL]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA <2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation [i.e. 2.1 log10 copies/mL] for the assay were set to the lower limit minus 0.1 [i.e. 2.0 log10 copies/mL]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (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 |
|---|---|---|---|
| 27862721 | Derived | Kumada H, Koike K, Suyama K, Ito H, Itoh H, Sugiura W. Efficacy and safety of tenofovir disoproxil fumarate rescue therapy for chronic hepatitis B patients who failed other nucleos(t)ide analogs. Hepatol Res. 2017 Sep;47(10):1032-1041. doi: 10.1111/hepr.12842. Epub 2016 Dec 21. |
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A total of 34 participants (13 participants in the Lamivudine [LAM]/ Tenofovir disoproxil fumarate [TDF] group and 21 participants in the Entecavir [ETV]/TDF group) were enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | LAM 100 mg/TDF 300 mg | Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks. |
| FG001 | ETV 0.5 mg/TDF 300 mg | Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LAM 100 mg/TDF 300 mg | Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks. |
| BG001 | ETV 0.5 mg/TDF 300 mg |
| 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 | Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24 | The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level < the lower limit of quantitation (2.1 log10 copies/millilitres[copies/mL]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA <2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method. | Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment. | Posted | Number | participants | Week 24 |
|
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 | LAM 100 mg/TDF 300 mg | Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Baseline and Week 24, Week 48 and Week 96 |
| Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96 | The number of participants with serum HBV DNA level < the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. | 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 hepatitis Be antigen (HBeAg)/hepatitis B e 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 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 hepatitis B surface antigen (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 was 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 With Virological Breakthrough and Resistance-related Mutations | The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase >=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered "negative" in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values. | Screening, Week 24, Week 48, Week 96 and Virological Breakthrough |
| Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96 | The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. | 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 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, >=6.0 log10) (kilo units 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 |
| Aichi |
| 467-8602 |
| Japan |
| GSK Investigational Site | Chiba | 260-8677 | Japan |
| GSK Investigational Site | Fukuoka | 803-8505 | Japan |
| GSK Investigational Site | Hiroshima | 734-8551 | Japan |
| GSK Investigational Site | Hokkaido | 060-0033 | Japan |
| GSK Investigational Site | Kagoshima | 890-8520 | Japan |
| GSK Investigational Site | Kanagawa | 213-8587 | Japan |
| GSK Investigational Site | Miyagi | 980-8574 | Japan |
| GSK Investigational Site | Tokyo | 105-8470 | Japan |
| GSK Investigational Site | Tokyo | 180-8610 | Japan |
Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | HER=Heritage | Number | Participants |
|
| OG001 | ETV 0.5 mg/TDF 300 mg | Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks. |
|
|
| Secondary | Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96 | The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation [i.e. 2.1 log10 copies/mL] for the assay were set to the lower limit minus 0.1 [i.e. 2.0 log10 copies/mL]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values. | FAS Population | Posted | Mean | 95% Confidence Interval | log10 copies/mL | Baseline and Week 24, Week 48 and Week 96 |
|
|
|
| Secondary | Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96 | The number of participants with serum HBV DNA level < the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values. | FAS Population. | Posted | Number | participants | Week 48 and Week 96 |
|
|
|
| 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 investigational product 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 |
|
|
|
| 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 | Posted | Number | participants | Week 24, Week 48 and Week 96 |
|
|
|
| Secondary | Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96 | The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e 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 change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values. | FAS Population | Posted | Number | participants | Week 24, Week 48 and Week 96 |
|
|
|
| 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 |
|
|
|
| Secondary | Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96 | The number of participants with hepatitis B surface antigen (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 was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values. | FAS Population | Posted | Number | participants | Week 24, Week 48 and Week 96 |
|
|
|
| Secondary | Number of Participants With Virological Breakthrough and Resistance-related Mutations | The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase >=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered "negative" in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values. | 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 |
|
|
|
| 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 hepatitis B surface antigen (HBsAg) category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. | FAS Population | Posted | Number | participants | Baseline, Week 24, Week 48 and Week 96 |
|
|
|
| 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 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, >=6.0 log10) (kilo units 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 |
|
|
|
| 1 |
| 13 |
| 12 |
| 13 |
| EG001 | ETV 0.5 mg/TDF 300 mg | Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks. | 2 | 21 | 17 | 21 |
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Asparatate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular 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 |
| Week 96 |
|
| Week 96 |
|
| Week 96 |
|
| Week 96 |
|
| Week 96 |
|
| Week 96 |
|
| ADV resistance-related mutations,Screening,n=13,21 |
|
| ETV resistance-related mutations,Screening,n=13,21 |
|
| LAM resistance-related mutations, Week 24, n=5, 9 |
|
| ADV resistance-related mutations, Week 24, n=5, 9 |
|
| ETV resistance-related mutations, Week 24, n=5, 9 |
|
| LAM resistance-related mutations, Week 48, n= 3, 9 |
|
| ADV resistance-related mutations, Week 48, n= 3, 9 |
|
| ETV resistance-related mutations, Week 48, n= 3, 9 |
|
| LAM resistance-related mutations, Week 96, n= 2, 7 |
|
| ADV resistance-related mutations, Week 96, n= 2, 7 |
|
| ETV resistance-related mutations, Week 96, n= 2, 7 |
|
| LAM resistance-related mutations, VB, n=0,1 |
|
| ADV resistance-related mutations, VB, n=0,1 |
|
| ETV resistance-related mutations, VB, n=0,1 |
|
| HBsAg 800-8000 KIU/L, Baseline |
|
| HBsAg 8000-80,000 KIU/L, Baseline |
|
| HBsAg >=80,000 KIU/L, Baseline |
|
| HBsAg <80 KIU/L, Week 24 |
|
| HBsAg 80-800 KIU/L, Week 24 |
|
| HBsAg 800-8000 KIU/L, Week 24 |
|
| HBsAg 8000-80,000 KIU/L, Week 24 |
|
| HBsAg >=80,000 KIU/L, Week 24 |
|
| HBsAg <80 KIU/L, Week 48 |
|
| HBsAg 80-800 KIU/L, Week 48 |
|
| HBsAg 800-8000 KIU/L, Week 48 |
|
| HBsAg 8000-80,000 KIU/L, Week 48 |
|
| HBsAg >=80,000 KIU/L, Week 48 |
|
| HBsAg <80 KIU/L, Week 96 |
|
| HBsAg 80-800 KIU/L, Week 96 |
|
| HBsAg 800-8000 KIU/L, Week 96 |
|
| HBsAg 8000-80,000 KIU/L, Week 96 |
|
| HBsAg >=80,000 KIU/L, Week 96 |
|
| HBcrAg 4.0-5.0 Log KU/L, Baseline |
|
| HBcrAg 5.0-6.0 Log KU/L, Baseline |
|
| HBcrAg >=6.0 Log KU/L, Baseline |
|
| HBcrAg <3.0 Log KU/L, Week 24 |
|
| HBcrAg 3.0-4.0 Log KU/L, Week 24 |
|
| HBcrAg 4.0-5.0 Log KU/L, Week 24 |
|
| HBcrAg 5.0-6.0 Log KU/L, Week 24 |
|
| HBcrAg >=6.0 Log KU/L, Week 24 |
|
| HBcrAg <3.0 Log KU/L, Week 48 |
|
| HBcrAg 3.0-4.0 Log KU/L, Week 48 |
|
| HBcrAg 4.0-5.0 Log KU/L, Week 48 |
|
| HBcrAg 5.0-6.0 Log KU/L, Week 48 |
|
| HBcrAg >=6.0 Log KU/L, Week 48 |
|
| HBcrAg <3.0 Log KU/L, Week 96 |
|
| HBcrAg 3.0-4.0 Log KU/L, Week 96 |
|
| HBcrAg 4.0-5.0 Log KU/L, Week 96 |
|
| HBcrAg 5.0-6.0 Log KU/L, Week 96 |
|
| HBcrAg >=6.0 Log KU/L, Week 96 |
|