| Primary | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm. In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included. | Full Analysis Set: participants who were randomized and received at least one dose of study drug | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG004 | Total TDF 12-17 Years | TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG005 | Total Placebo 12-17 Years | TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
| | Units | Counts |
|---|
| Participants | - OG00010
- OG00142
- OG00213
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00090.0
- OG00188.1
- OG0020
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group. | Cochran-Mantel-Haenszel | | < 0.001 | A p-value of < 0.05 was considered statistically significant. | | | | | | | | | | | | No | Superiority or Other | | |
|
| Primary | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192. | Safety Analysis Set: participants who received at least one dose of study drug. | Posted | | Number | | percentage of participants | | Baseline to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | | Posted | | Number | | percentage of participants | | Weeks 48, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | | Posted | | Number | | percentage of participants | | Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | | Posted | | Number | | percentage of participants | | Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | | Posted | | Number | | percentage of participants | | Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F. | | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F. | | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | |
|
| Secondary | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis). | | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis). | | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Spine BMD at Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 72 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Spine BMD at Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 96 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Spine BMD at Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 144 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Spine BMD at Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Whole Body BMD at Week 48 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Whole Body BMD at Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 72 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Whole Body BMD at Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 96 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Whole Body BMD at Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 144 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Percent Change From Baseline in Whole Body BMD at Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage change | | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Spine BMD at Week 48 | To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject's recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject's recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Spine BMD at Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 72 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Spine BMD at Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 96 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Spine BMD at Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 144 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Spine BMD at Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Whole Body BMD at Week 48 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Whole Body BMD at Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 72 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Whole Body BMD at Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 96 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Whole Body BMD at Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 144 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Change From Baseline in Z-score for Whole Body BMD at Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | z-score | | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years | TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
|
| Secondary | Number of Participants With Changes in Drug-Resistant Mutations During the Study | The number of participants with changes in drug-resistant mutations during the study was summarized. | Participants with HBV DNA ≥ 400 copies/mL, with confirmed virologic breakthrough (defined as 2 consecutive increases in HBV DNA of at least 10-fold from nadir, or confirmed values ≥ 400 copies/mL after being < 400 copies/mL while on study medication), or subjects who discontinued early (after Week 24 with HBV DNA ≥ 400 copies/mL) were analyzed. | Posted | | Number | | participants | | Baseline through Week 192 | | | | ID | Title | Description |
|---|
| OG000 | Total TDF 12-17 Years | TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | Total Placebo 12-17 Years | TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase |
| |
| Secondary | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 | Placebo 15-17 Years |
|
| Secondary | Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. | Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Weeks 48, 72, 96, 144, and 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF 12-14 Years | TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG001 | TDF 15-17 Years | TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG002 | Placebo 12-14 Years | TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase | | OG003 |
|