Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects will be assessed for eligibility at a screening visit, with eligible subjects returning for a baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase all enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally once daily. All the eligible study subjects will undergo safety and efficacy assessments every 12 weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of tenofovir (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding and after incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain. TDF is a highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB patients. The purpose of our study is to evaluate the efficacy of TDF treatment in Chinese CHB patients following failure of multiple NAs. In addition, the study will also explore the relationship of baseline factors and early HBV DNA suppression to long-term virological response. The efficacy of TDF in multi-drug resistant patients will be analysed separately. The data generated by this study could then be used to optimize the clinical application of TDF and provide new evidence for management of the HBV infections following failure of multiple NAs. The result of this study will help Chinese physicians better manage the CHB patients following failure of multiple NAs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Experimental | All enrolled subjects will receive open label TDF at a dose of 300 milligram (mg) orally once daily during the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate | Drug | Tenofovir disoproxil fumarate tablets supplied will be white, almond-shaped, film-coated tablets containing 300 mg of TDF. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinised starch, croscarmellose sodium, and magnesium stearate. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144 | HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA <20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication. | At Week 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV <20 IU/mL and <69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA <20 IU/mL and <69 IU/mL at Weeks 48 and 96 have been presented. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guangzhou | Guangdong | 510060 | China | ||
| GSK Investigational Site |
A total of 281 participants were screened; of these 68 were screen failures. A total of 213 participants entered the treatment phase of the study.
This study was conducted to evaluate the efficacy and safety of Tenofovir Disoproxil Fumarate treatment in Chinese chronic hepatitis B (CHB) participants following failure of multiple Nucleos(t)ide analogues(NAs) at different centers in China.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tenofovir Disoproxil Fumerate 300 mg | Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2018 | Jul 3, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| At Weeks 48 and 96 |
| Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA <20 IU/mL and serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 have been presented. | At Weeks 48, 96, and 144 |
| Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks 48,96, and 144 |
| Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. | At Weeks 48, 96 and 144 |
| Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Serological response was assessed at Weeks 48, 96 and 144 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. | At Weeks 48,96, and 144 |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline | Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented. | At Weeks 48, 96, and 144 |
| Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented. | At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE occurred on or after the first dose date of study drug, SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment. | Up to Week 144 |
| Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Blood samples were collected to analyze the hematology parameters: WBC, basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 |
| Change From Baseline in Hemoglobin (Hb) | Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 |
| Change From Baseline in Red Blood Cells (RBC) | Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 |
| Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144 |
| Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
| Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
| Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, phosphorus, calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
| Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Blood samples were collected to analyze the chemistry parameter: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
| Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Blood samples were collected to analyze the chemistry parameter: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
| Guangzhou |
| Guangdong |
| 510150 |
| China |
| GSK Investigational Site | Changchun | Jilin | China |
| GSK Investigational Site | Chengdu | Sichuan | 610041 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310000 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | 100044 | China |
| GSK Investigational Site | Beijing | 100050 | China |
| GSK Investigational Site | Beijing | 100054 | China |
| GSK Investigational Site | Shanghai | 200025 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Zhengzhou | China |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tenofovir Disoproxil Fumerate 300 mg | Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-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 | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144 | HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA <20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication. | mITT Population. | Posted | Number | Percentage of Participants | At Week 144 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 | HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV <20 IU/mL and <69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA <20 IU/mL and <69 IU/mL at Weeks 48 and 96 have been presented. | mITT Population. | Posted | Number | Percentage of Participants | At Weeks 48 and 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 | Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA <20 IU/mL and serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 have been presented. | mITT Population. | Posted | Number | Percentage of Participants | At Weeks 48, 96, and 144 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 | Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | mITT Population. All the participants in the study were analyzed (213 Participants) but only the participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Log 10 (IU/mL) | Baseline (Day 0) and at Weeks 48,96, and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Number | Percentage of Participants | At Weeks 48, 96 and 144 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 | Serological response was assessed at Weeks 48, 96 and 144 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Number | Percentage of Participants | At Weeks 48,96, and 144 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline | Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Number | Percentage of Participants | At Weeks 48, 96, and 144 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 | Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented. | mITT Population. | Posted | Number | Percentage of Participants | At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE occurred on or after the first dose date of study drug, SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment. | Safety Analysis Population. | Posted | Number | Participants | Up to Week 144 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets | Blood samples were collected to analyze the hematology parameters: WBC, basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Billion cells per liter | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin (Hb) | Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Red Blood Cells (RBC) | Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) | Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine | Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. | Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, phosphorus, calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate | Blood samples were collected to analyze the chemistry parameter: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Milliliter per minute | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) | Blood samples were collected to analyze the chemistry parameter: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. | Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144 |
|
|
On-treatment non-serious adverse events and serious adverse events were collected up to 144 weeks from the start of the treatment
Safety analysis population was used to collect the adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenofovir Disoproxil Fumerate 300 mg | Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks. | 1 | 213 | 20 | 213 | 117 | 213 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Systematic Assessment |
| |
| Testicular seminoma (pure) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Myocardial bridging | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Adrenal cyst | Endocrine disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Epididymal cyst | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Papilloma viral infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Ultrasound liver abnormal | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Reflux gastritis | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hepatic fibrosis | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Steatohepatitis | Hepatobiliary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Calculus prostatic | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Prostatic disorder | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Achromotrichia acquired | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Bone formation increased | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hamartoma | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 21.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 21, 2015 | Jul 5, 2019 | Prot_001.pdf |
| 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 |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|