Hepatitis B Virus (HBV)
Conditions
Keywords
tenofovir, adolescents, chronic hepatitis B
Brief summary
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection. The optimal treatment for adolescents with chronic HBV infection is currently unknown. Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations has been shown to be less than optimal. Further, the safety and efficacy of entecavir and telbivudine have not been established in patients \< 16 years of age. A study evaluating TDF in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the treatment of chronic hepatitis B in this patient population. In addition, the study will help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their participation, study participants will help generate critical new information to help guide the most optimal treatment of chronic HBV infection in adolescents. This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks of blinded treatment, participants were to switch to open-label TDF for an additional 2.5 years of treatment, provided that no safety concerns are identified by the Independent Data Monitoring Committee monitoring the study.
Interventions
TDF administered as a 300-mg tablet once daily
DRUGPlacebo
TDF placebo tablet once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 12 through 17 years of age, inclusive (consent of parent/legal guardian required) * Documented chronic HBV infection * HBeAg positive or HBeAg negative * Weight \> 35 kg * Able to swallow oral tablets * HBV DNA \> 100,000 copies/mL (polymerase chain reaction (PCR) method) * Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN) at screening, OR any history of ALT \> 2 × ULN over the past 24 months * Willing and able to provide written informed consent/assent (child and parent/legal guardian) * Negative serum pregnancy test (for postmenarchal females only) * Estimated glomerular filtration rate (creatinine clearance \[using the Schwartz formula\]) \> 80 mL/min/1.73m\^2 * Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm\^3; hemoglobin ≥ 10.0 g/dL) * No prior TDF therapy (participants may have received prior interferon or oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon therapy ≥ 6 months prior to screening; participants experienced on anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)
Exclusion criteria
* Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study * Males and females of reproductive potential who are not willing to use an effective method of contraception during the study * Decompensated liver disease * Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit * Receipt of anti-HBV nucleoside/nucleotide therapy within 16 weeks of the Screening Visit * Alpha fetoprotein \> 50 ng/mL * Evidence of hepatocellular carcinoma (HCC) * Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV) * History of significant renal disease (eg, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease) * History of significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures) * Significant cardiovascular, pulmonary, or neurological disease * Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications * History of solid organ or bone marrow transplantation * Ongoing therapy with nephrotoxic agents, competitors of renal excretion, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2 (IL-2), or other immunomodulating or investigational agents * Known hypersensitivity to the study drugs, the metabolites or formulation excipients * Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the participants unsuitable for the study or unable to comply with dosing requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 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. |
| Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | 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. |
| Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | 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. |
| Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | 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. |
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Baseline; 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. |
| Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Baseline; 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. |
| Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Baseline; 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). |
| Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Baseline; 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). |
| Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | Baseline; Week 48 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Spine BMD at Week 72 | Baseline; Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Spine BMD at Week 96 | Baseline; Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Spine BMD at Week 144 | Baseline; Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Spine BMD at Week 192 | Baseline; Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Whole Body BMD at Week 48 | Baseline; Week 48 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Whole Body BMD at Week 72 | Baseline; Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Whole Body BMD at Week 96 | Baseline; Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percent Change From Baseline in Whole Body BMD at Week 144 | Baseline; Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Spine BMD at Week 96 | Baseline; Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Spine BMD at Week 48 | Baseline; 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). |
| Change From Baseline in Z-score for Spine BMD at Week 72 | Baseline; Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Spine BMD at Week 144 | Baseline; Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Spine BMD at Week 192 | Baseline; Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Whole Body BMD at Week 48 | Baseline; Week 48 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Whole Body BMD at Week 72 | Baseline; Week 72 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Whole Body BMD at Week 96 | Baseline; Week 96 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Whole Body BMD at Week 144 | Baseline; Week 144 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Change From Baseline in Z-score for Whole Body BMD at Week 192 | Baseline; Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Number of Participants With Changes in Drug-Resistant Mutations During the Study | Baseline through Week 192 | The number of participants with changes in drug-resistant mutations during the study was summarized. |
| Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Baseline; 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. |
| Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Baseline; 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. |
| 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 | Baseline; 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. |
| Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Baseline; 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. |
| 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 | Baseline; 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. |
| 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 | Baseline; 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. |
| Percent Change From Baseline in Whole Body BMD at Week 192 | Baseline; Week 192 | Data were summarized by treatment and age group (grouped by baseline age for analysis). |
| Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | 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. |
Countries
Bulgaria, France, Poland, Romania, Spain, Turkey (Türkiye), United States
Participant flow
Recruitment details
Participants were enrolled at 3 sites in the United States, 8 sites in Poland, 3 sites in Romania, 2 sites in Bulgaria, 2 sites in France, 2 sites in Spain, and 1 site in Turkey. The first participant was screened on 03 December 2008. The last study visit occurred on 02 December 2015.
Pre-assignment details
149 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 42 |
| 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 | 13 |
| 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 | 41 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Open-Label Phase | Did Not Meet Entrance Criteria | 0 | 0 | 0 | 1 |
| Open-Label Phase | Lost to Follow-up | 1 | 2 | 0 | 1 |
| Open-Label Phase | Safety, Tolerability or Efficacy Reasons | 1 | 0 | 0 | 0 |
| Open-Label Phase | Withdrew Consent | 1 | 0 | 1 | 1 |
| Randomized Phase (Through Week 72) | Investigator's Discretion | 0 | 1 | 0 | 2 |
| Randomized Phase (Through Week 72) | Per protocol ALT elevation | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo 15-17 Years | Placebo 12-14 Years | TDF 12-14 Years | TDF 15-17 Years |
|---|---|---|---|---|---|
| Age, Continuous | 15.4 years STANDARD_DEVIATION 1.38 | 15.9 years STANDARD_DEVIATION 0.82 | 13.2 years STANDARD_DEVIATION 0.69 | 13.3 years STANDARD_DEVIATION 0.82 | 16.1 years STANDARD_DEVIATION 0.75 |
| Alanine aminotransferase (ALT) level at baseline | 101 U/L STANDARD_DEVIATION 98.5 | 101 U/L STANDARD_DEVIATION 89.5 | 101 U/L STANDARD_DEVIATION 95.4 | 77 U/L STANDARD_DEVIATION 54.8 | 106 U/L STANDARD_DEVIATION 116.4 |
| ALT normal at baseline Abnormal | 77 participants | 33 participants | 9 participants | 7 participants | 28 participants |
| ALT normal at baseline Normal | 29 participants | 8 participants | 4 participants | 3 participants | 14 participants |
| HBV DNA level at baseline | 8.13 Log_10 copies/mL STANDARD_DEVIATION 1.403 | 8.12 Log_10 copies/mL STANDARD_DEVIATION 1.451 | 8.61 Log_10 copies/mL STANDARD_DEVIATION 1.166 | 8.26 Log_10 copies/mL STANDARD_DEVIATION 1.455 | 7.95 Log_10 copies/mL STANDARD_DEVIATION 1.421 |
| HBV Genotype Genotype A | 69 participants | 29 participants | 5 participants | 5 participants | 30 participants |
| HBV Genotype Genotype B | 3 participants | 1 participants | 1 participants | 0 participants | 1 participants |
| HBV Genotype Genotype C | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| HBV Genotype Genotype D | 33 participants | 11 participants | 7 participants | 5 participants | 10 participants |
| Hepatitis B e Antigen (HBeAg) status at baseline Negative | 10 participants | 6 participants | 0 participants | 1 participants | 3 participants |
| Hepatitis B e Antigen (HBeAg) status at baseline Positive | 96 participants | 35 participants | 13 participants | 9 participants | 39 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 5 participants | 4 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 98 participants | 37 participants | 12 participants | 10 participants | 39 participants |
| Region of Enrollment Bulgaria | 7 participants | 1 participants | 3 participants | 0 participants | 3 participants |
| Region of Enrollment Europe | 101 participants | 39 participants | 12 participants | 10 participants | 40 participants |
| Region of Enrollment France | 2 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment North America | 5 participants | 2 participants | 1 participants | 0 participants | 2 participants |
| Region of Enrollment Poland | 74 participants | 31 participants | 6 participants | 6 participants | 31 participants |
| Region of Enrollment Romania | 14 participants | 4 participants | 2 participants | 4 participants | 4 participants |
| Region of Enrollment Spain | 2 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Turkey | 2 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 5 participants | 2 participants | 1 participants | 0 participants | 2 participants |
| Sex: Female, Male Female | 33 Participants | 15 Participants | 4 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 73 Participants | 26 Participants | 9 Participants | 7 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 52 | 40 / 54 | 30 / 51 | 31 / 52 |
| serious Total, serious adverse events | 5 / 52 | 11 / 54 | 8 / 51 | 10 / 52 |
Outcome results
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.
Time frame: Baseline to Week 72
Population: Safety Analysis Set: participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | 2.4 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | 1.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 | 0 percentage of participants |
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.
Time frame: Week 72
Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 90.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 88.1 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 88.5 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 | 0 percentage of participants |
Comparison: Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.p-value: <0.001Cochran-Mantel-Haenszel
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).
Time frame: Baseline; Week 144
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 144 | -0.20 z-score | Standard Deviation 0.56 |
| TDF 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 144 | -0.05 z-score | Standard Deviation 0.417 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 144 | -0.16 z-score | Standard Deviation 0.625 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 144 | -0.04 z-score | Standard Deviation 0.405 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 144 | -0.08 z-score | Standard Deviation 0.447 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 144 | -0.06 z-score | Standard Deviation 0.455 |
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).
Time frame: Baseline; Week 192
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 192 | -0.24 z-score | Standard Deviation 0.518 |
| TDF 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 192 | 0.08 z-score | Standard Deviation 0.544 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 192 | -0.26 z-score | Standard Deviation 0.654 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 192 | -0.05 z-score | Standard Deviation 0.504 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 192 | 0.02 z-score | Standard Deviation 0.548 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 192 | -0.10 z-score | Standard Deviation 0.543 |
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).
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 48 | 0.02 z-score | Standard Deviation 0.247 |
| TDF 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 48 | -0.10 z-score | Standard Deviation 0.255 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 48 | 0.04 z-score | Standard Deviation 0.393 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 48 | 0.05 z-score | Standard Deviation 0.322 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 48 | -0.08 z-score | Standard Deviation 0.256 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 48 | 0.05 z-score | Standard Deviation 0.337 |
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).
Time frame: Baseline; Week 72
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 72 | -0.10 z-score | Standard Deviation 0.312 |
| TDF 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 72 | -0.05 z-score | Standard Deviation 0.325 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 72 | 0.09 z-score | Standard Deviation 0.498 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 72 | 0.10 z-score | Standard Deviation 0.339 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 72 | -0.06 z-score | Standard Deviation 0.32 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 72 | 0.10 z-score | Standard Deviation 0.378 |
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).
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 96 | -0.19 z-score | Standard Deviation 0.365 |
| TDF 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 96 | -0.07 z-score | Standard Deviation 0.356 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Spine BMD at Week 96 | -0.02 z-score | Standard Deviation 0.498 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Spine BMD at Week 96 | -0.13 z-score | Standard Deviation 0.414 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 96 | -0.10 z-score | Standard Deviation 0.357 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Spine BMD at Week 96 | -0.11 z-score | Standard Deviation 0.431 |
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).
Time frame: Baseline; Week 144
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 144 | -0.27 z-score | Standard Deviation 0.431 |
| TDF 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 144 | -0.21 z-score | Standard Deviation 0.473 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 144 | -0.06 z-score | Standard Deviation 0.554 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 144 | -0.16 z-score | Standard Deviation 0.468 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 144 | -0.22 z-score | Standard Deviation 0.462 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 144 | -0.14 z-score | Standard Deviation 0.484 |
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).
Time frame: Baseline; Week 192
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 192 | -0.34 z-score | Standard Deviation 0.499 |
| TDF 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 192 | -0.11 z-score | Standard Deviation 0.524 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 192 | -0.21 z-score | Standard Deviation 0.486 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 192 | -0.19 z-score | Standard Deviation 0.517 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 192 | -0.16 z-score | Standard Deviation 0.521 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 192 | -0.19 z-score | Standard Deviation 0.504 |
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).
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 48 | 0.02 z-score | Standard Deviation 0.426 |
| TDF 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 48 | -0.15 z-score | Standard Deviation 0.257 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 48 | 0.10 z-score | Standard Deviation 0.37 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 48 | 0.04 z-score | Standard Deviation 0.308 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 48 | -0.12 z-score | Standard Deviation 0.298 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 48 | 0.05 z-score | Standard Deviation 0.322 |
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).
Time frame: Baseline; Week 72
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 72 | 0.02 z-score | Standard Deviation 0.398 |
| TDF 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 72 | -0.19 z-score | Standard Deviation 0.338 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 72 | 0.20 z-score | Standard Deviation 0.45 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 72 | 0.06 z-score | Standard Deviation 0.306 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 72 | -0.16 z-score | Standard Deviation 0.355 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 72 | 0.09 z-score | Standard Deviation 0.349 |
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).
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 96 | -0.12 z-score | Standard Deviation 0.294 |
| TDF 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 96 | -0.19 z-score | Standard Deviation 0.451 |
| Placebo 12-14 Years | Change From Baseline in Z-score for Whole Body BMD at Week 96 | 0.09 z-score | Standard Deviation 0.528 |
| Placebo 15-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 96 | -0.06 z-score | Standard Deviation 0.432 |
| Total TDF 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 96 | -0.18 z-score | Standard Deviation 0.424 |
| Total Placebo 12-17 Years | Change From Baseline in Z-score for Whole Body BMD at Week 96 | -0.03 z-score | Standard Deviation 0.456 |
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.
Time frame: Baseline through Week 192
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Number of Participants With Changes in Drug-Resistant Mutations During the Study | New TDF Drug-Resistant Mutations | 0 participants |
| TDF 12-14 Years | Number of Participants With Changes in Drug-Resistant Mutations During the Study | Enrichment of TDF Drug-Resistant Mutations | 0 participants |
| TDF 15-17 Years | Number of Participants With Changes in Drug-Resistant Mutations During the Study | New TDF Drug-Resistant Mutations | 0 participants |
| TDF 15-17 Years | Number of Participants With Changes in Drug-Resistant Mutations During the Study | Enrichment of TDF Drug-Resistant Mutations | 0 participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 44.4 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 11.1 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 11.1 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 33.3 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 44.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 23.1 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 38.5 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 17.9 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 43.6 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 30.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 23.1 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 38.5 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 7.7 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 28.6 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 8.6 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 11.4 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 34.3 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 37.1 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 39.6 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 16.7 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 41.7 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 20.8 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 33.3 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 8.3 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 39.6 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 14.6 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 41.7 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 31.3 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 33.3 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 11.1 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 11.1 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 33.3 percentage of participants |
| TDF 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 44.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 23.1 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 38.5 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 15.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 38.5 percentage of participants |
| TDF 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 30.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 23.1 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 38.5 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 7.7 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 25.7 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 8.6 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 11.4 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 34.3 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 37.1 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 37.5 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 14.6 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 37.5 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 20.8 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 33.3 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 8.3 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 39.6 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 14.6 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 41.7 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 29.2 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | 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 | Week 144 | 22.2 percentage of participants |
| TDF 12-14 Years | 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 | Week 72 | 11.1 percentage of participants |
| TDF 12-14 Years | 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 | Week 48 | 11.1 percentage of participants |
| TDF 12-14 Years | 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 | Week 192 | 33.3 percentage of participants |
| TDF 12-14 Years | 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 | Week 96 | 44.4 percentage of participants |
| TDF 15-17 Years | 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 | Week 72 | 15.4 percentage of participants |
| TDF 15-17 Years | 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 | Week 144 | 30.8 percentage of participants |
| TDF 15-17 Years | 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 | Week 48 | 12.8 percentage of participants |
| TDF 15-17 Years | 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 | Week 192 | 28.2 percentage of participants |
| TDF 15-17 Years | 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 | Week 96 | 28.2 percentage of participants |
| Placebo 12-14 Years | 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 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | 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 | Week 144 | 46.2 percentage of participants |
| Placebo 12-14 Years | 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 | Week 192 | 46.2 percentage of participants |
| Placebo 12-14 Years | 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 | Week 96 | 30.8 percentage of participants |
| Placebo 12-14 Years | 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 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 96 | 22.9 percentage of participants |
| Placebo 15-17 Years | 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 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 144 | 25.7 percentage of participants |
| Placebo 15-17 Years | 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 | Week 192 | 25.7 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 144 | 29.2 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 48 | 12.5 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 192 | 29.2 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 72 | 14.6 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 96 | 31.3 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 144 | 31.3 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 192 | 31.3 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 96 | 25.0 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | 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 | Week 144 | 33.3 percentage of participants |
| TDF 12-14 Years | 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 | Week 72 | 16.7 percentage of participants |
| TDF 12-14 Years | 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 | Week 48 | 16.7 percentage of participants |
| TDF 12-14 Years | 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 | Week 192 | 50.0 percentage of participants |
| TDF 12-14 Years | 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 | Week 96 | 50.0 percentage of participants |
| TDF 15-17 Years | 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 | Week 72 | 22.2 percentage of participants |
| TDF 15-17 Years | 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 | Week 144 | 29.6 percentage of participants |
| TDF 15-17 Years | 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 | Week 48 | 18.5 percentage of participants |
| TDF 15-17 Years | 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 | Week 192 | 29.6 percentage of participants |
| TDF 15-17 Years | 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 | Week 96 | 33.3 percentage of participants |
| Placebo 12-14 Years | 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 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | 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 | Week 144 | 55.6 percentage of participants |
| Placebo 12-14 Years | 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 | Week 192 | 55.6 percentage of participants |
| Placebo 12-14 Years | 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 | Week 96 | 33.3 percentage of participants |
| Placebo 12-14 Years | 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 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 96 | 24.2 percentage of participants |
| Placebo 15-17 Years | 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 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 144 | 27.3 percentage of participants |
| Placebo 15-17 Years | 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 | Week 192 | 27.3 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 144 | 30.3 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 48 | 18.2 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 192 | 33.3 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 72 | 21.2 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 96 | 36.4 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 144 | 33.3 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 192 | 33.3 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 96 | 26.2 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | 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 | Week 144 | 57.1 percentage of participants |
| TDF 12-14 Years | 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 | Week 72 | 85.7 percentage of participants |
| TDF 12-14 Years | 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 | Week 48 | 85.7 percentage of participants |
| TDF 12-14 Years | 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 | Week 192 | 85.7 percentage of participants |
| TDF 12-14 Years | 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 | Week 96 | 85.7 percentage of participants |
| TDF 15-17 Years | 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 | Week 72 | 71.4 percentage of participants |
| TDF 15-17 Years | 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 | Week 144 | 71.4 percentage of participants |
| TDF 15-17 Years | 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 | Week 48 | 71.4 percentage of participants |
| TDF 15-17 Years | 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 | Week 192 | 67.9 percentage of participants |
| TDF 15-17 Years | 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 | Week 96 | 78.6 percentage of participants |
| Placebo 12-14 Years | 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 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | 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 | Week 144 | 66.7 percentage of participants |
| Placebo 12-14 Years | 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 | Week 192 | 77.8 percentage of participants |
| Placebo 12-14 Years | 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 | Week 96 | 55.6 percentage of participants |
| Placebo 12-14 Years | 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 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 96 | 54.5 percentage of participants |
| Placebo 15-17 Years | 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 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | 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 | Week 144 | 69.7 percentage of participants |
| Placebo 15-17 Years | 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 | Week 192 | 57.6 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 144 | 68.6 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 48 | 74.3 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 192 | 71.4 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 72 | 74.3 percentage of participants |
| Total TDF 12-17 Years | 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 | Week 96 | 80.0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 144 | 69.0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 192 | 61.9 percentage of participants |
| Total Placebo 12-17 Years | 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 | Week 96 | 54.8 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 57.1 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 85.7 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 85.7 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 85.7 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 85.7 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 71.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 71.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 71.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 75.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 78.6 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 22.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 66.7 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 77.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 66.7 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 11.1 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 63.6 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 21.2 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 33.3 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 72.7 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 69.7 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 68.6 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 74.3 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 77.1 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 74.3 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 80.0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 19.0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 71.4 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 31.0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 71.4 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 64.3 percentage of participants |
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).
Time frame: Baseline; Weeks 48, 96, 144, and 192
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 144 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 96 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 192 | 4.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 192 | 4.9 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 144 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 192 | 3.8 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 96 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 192 | 3.7 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
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).
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 144 | 2.4 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 192 | 2.4 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 144 | 1.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 192 | 1.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 2.4 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 1.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
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.
Time frame: Weeks 48, 72, 96, 144, and 192
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 144 | 90.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 72 | 90.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 48 | 80.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 192 | 90.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 96 | 90.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 72 | 83.3 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 144 | 88.1 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 48 | 81.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 192 | 83.3 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 96 | 88.1 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 144 | 69.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 192 | 76.9 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 96 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 96 | 63.4 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 144 | 82.9 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 192 | 73.2 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 144 | 88.5 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 48 | 80.8 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 192 | 84.6 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 72 | 84.6 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 96 | 88.5 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 144 | 79.6 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 192 | 74.1 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 | Week 96 | 61.1 percentage of participants |
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.
Time frame: Weeks 48, 72, 96, 144, and 192
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 60.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 80.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 70.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 80.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 80.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 69.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 69.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 69.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 64.3 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 73.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 69.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 46.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 51.2 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 68.3 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 63.4 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 67.3 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 69.2 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 67.3 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 71.2 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 75.0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 144 | 64.8 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 192 | 64.8 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 | Week 96 | 50.0 percentage of participants |
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.
Time frame: Weeks 48, 96, 144, and 192
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 48 | 90.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 96 | 90.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 144 | 100.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 192 | 90.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 144 | 90.5 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 96 | 88.1 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 48 | 85.7 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 192 | 85.7 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 192 | 76.9 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 144 | 69.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 96 | 53.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 192 | 73.2 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 96 | 68.3 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 144 | 85.4 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 144 | 92.3 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 192 | 86.5 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 96 | 88.5 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 48 | 86.5 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 96 | 64.8 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 144 | 81.5 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 192 | 74.1 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 | Week 48 | 0 percentage of participants |
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.
Time frame: Baseline; Weeks 48, 72, 96, 144, and 192
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 2.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 2.4 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 1.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 1.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 48 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 144 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 72 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 192 | 0 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 | Week 96 | 0 percentage of participants |
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.
Time frame: Weeks 48, 72, 96, 144, and 192
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 144 | 60.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 72 | 80.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 48 | 70.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 192 | 80.0 percentage of participants |
| TDF 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 96 | 80.0 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 72 | 76.2 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 144 | 71.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 48 | 76.2 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 192 | 71.4 percentage of participants |
| TDF 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 96 | 76.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 72 | 30.8 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 144 | 69.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 192 | 84.6 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 96 | 69.2 percentage of participants |
| Placebo 12-14 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 48 | 30.8 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 96 | 65.9 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 48 | 26.8 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 72 | 41.5 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 144 | 75.6 percentage of participants |
| Placebo 15-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 192 | 75.6 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 144 | 69.2 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 48 | 75.0 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 192 | 73.1 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 72 | 76.9 percentage of participants |
| Total TDF 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 96 | 76.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 48 | 27.8 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 144 | 74.1 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 72 | 38.9 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 192 | 77.8 percentage of participants |
| Total Placebo 12-17 Years | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 | Week 96 | 66.7 percentage of participants |
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).
Time frame: Baseline; Week 144
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Spine BMD at Week 144 | 19.224 percentage change | Standard Deviation 8.7594 |
| TDF 15-17 Years | Percent Change From Baseline in Spine BMD at Week 144 | 5.289 percentage change | Standard Deviation 5.8084 |
| Placebo 12-14 Years | Percent Change From Baseline in Spine BMD at Week 144 | 21.346 percentage change | Standard Deviation 13.4709 |
| Placebo 15-17 Years | Percent Change From Baseline in Spine BMD at Week 144 | 6.144 percentage change | Standard Deviation 8.3286 |
| Total TDF 12-17 Years | Percent Change From Baseline in Spine BMD at Week 144 | 8.133 percentage change | Standard Deviation 8.5611 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Spine BMD at Week 144 | 9.311 percentage change | Standard Deviation 11.3262 |
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).
Time frame: Baseline; Week 192
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Spine BMD at Week 192 | 23.933 percentage change | Standard Deviation 8.5166 |
| TDF 15-17 Years | Percent Change From Baseline in Spine BMD at Week 192 | 6.673 percentage change | Standard Deviation 7.287 |
| Placebo 12-14 Years | Percent Change From Baseline in Spine BMD at Week 192 | 25.036 percentage change | Standard Deviation 14.2346 |
| Placebo 15-17 Years | Percent Change From Baseline in Spine BMD at Week 192 | 6.867 percentage change | Standard Deviation 9.3736 |
| Total TDF 12-17 Years | Percent Change From Baseline in Spine BMD at Week 192 | 10.050 percentage change | Standard Deviation 10.1637 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Spine BMD at Week 192 | 11.212 percentage change | Standard Deviation 13.1459 |
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).
Time frame: Baseline; Week 72
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Spine BMD at Week 72 | 11.516 percentage change | Standard Deviation 3.8818 |
| TDF 15-17 Years | Percent Change From Baseline in Spine BMD at Week 72 | 3.589 percentage change | Standard Deviation 4.5633 |
| Placebo 12-14 Years | Percent Change From Baseline in Spine BMD at Week 72 | 14.131 percentage change | Standard Deviation 9.9563 |
| Placebo 15-17 Years | Percent Change From Baseline in Spine BMD at Week 72 | 6.117 percentage change | Standard Deviation 6.0624 |
| Total TDF 12-17 Years | Percent Change From Baseline in Spine BMD at Week 72 | 5.144 percentage change | Standard Deviation 5.4291 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Spine BMD at Week 72 | 8.080 percentage change | Standard Deviation 7.8996 |
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).
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Spine BMD at Week 96 | 13.811 percentage change | Standard Deviation 4.6712 |
| TDF 15-17 Years | Percent Change From Baseline in Spine BMD at Week 96 | 4.196 percentage change | Standard Deviation 4.8021 |
| Placebo 12-14 Years | Percent Change From Baseline in Spine BMD at Week 96 | 16.687 percentage change | Standard Deviation 10.4359 |
| Placebo 15-17 Years | Percent Change From Baseline in Spine BMD at Week 96 | 4.272 percentage change | Standard Deviation 7.0463 |
| Total TDF 12-17 Years | Percent Change From Baseline in Spine BMD at Week 96 | 6.119 percentage change | Standard Deviation 6.12 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Spine BMD at Week 96 | 7.003 percentage change | Standard Deviation 9.3658 |
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).
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | 9.234 percentage change | Standard Deviation 3.4782 |
| TDF 15-17 Years | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | 2.114 percentage change | Standard Deviation 3.6023 |
| Placebo 12-14 Years | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | 9.038 percentage change | Standard Deviation 6.6575 |
| Placebo 15-17 Years | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | 4.435 percentage change | Standard Deviation 4.9091 |
| Total TDF 12-17 Years | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | 3.510 percentage change | Standard Deviation 4.5507 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | 5.562 percentage change | Standard Deviation 5.6772 |
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).
Time frame: Baseline; Week 144
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 144 | 10.940 percentage change | Standard Deviation 4.8819 |
| TDF 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 144 | 3.529 percentage change | Standard Deviation 3.1734 |
| Placebo 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 144 | 12.638 percentage change | Standard Deviation 5.9973 |
| Placebo 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 144 | 4.730 percentage change | Standard Deviation 5.2213 |
| Total TDF 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 144 | 4.949 percentage change | Standard Deviation 4.5753 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 144 | 6.505 percentage change | Standard Deviation 6.2944 |
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).
Time frame: Baseline; Week 192
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 192 | 13.923 percentage change | Standard Deviation 4.6139 |
| TDF 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 192 | 4.295 percentage change | Standard Deviation 3.7318 |
| Placebo 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 192 | 14.797 percentage change | Standard Deviation 6.4993 |
| Placebo 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 192 | 4.549 percentage change | Standard Deviation 5.4494 |
| Total TDF 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 192 | 6.086 percentage change | Standard Deviation 5.4029 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 192 | 7.223 percentage change | Standard Deviation 7.2666 |
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).
Time frame: Baseline; Week 48
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 48 | 5.123 percentage change | Standard Deviation 3.8309 |
| TDF 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 48 | 1.339 percentage change | Standard Deviation 1.9324 |
| Placebo 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 48 | 5.470 percentage change | Standard Deviation 3.4958 |
| Placebo 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 48 | 3.236 percentage change | Standard Deviation 2.8573 |
| Total TDF 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 48 | 2.048 percentage change | Standard Deviation 2.783 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 48 | 3.817 percentage change | Standard Deviation 3.1576 |
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).
Time frame: Baseline; Week 72
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 72 | 7.282 percentage change | Standard Deviation 3.9156 |
| TDF 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 72 | 2.141 percentage change | Standard Deviation 2.6284 |
| Placebo 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 72 | 8.480 percentage change | Standard Deviation 4.477 |
| Placebo 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 72 | 4.335 percentage change | Standard Deviation 3.4073 |
| Total TDF 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 72 | 3.067 percentage change | Standard Deviation 3.4819 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 72 | 5.391 percentage change | Standard Deviation 4.0902 |
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).
Time frame: Baseline; Week 96
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TDF 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 96 | 8.034 percentage change | Standard Deviation 3.4973 |
| TDF 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 96 | 3.023 percentage change | Standard Deviation 3.2063 |
| Placebo 12-14 Years | Percent Change From Baseline in Whole Body BMD at Week 96 | 10.056 percentage change | Standard Deviation 5.4296 |
| Placebo 15-17 Years | Percent Change From Baseline in Whole Body BMD at Week 96 | 4.291 percentage change | Standard Deviation 4.3195 |
| Total TDF 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 96 | 3.943 percentage change | Standard Deviation 3.773 |
| Total Placebo 12-17 Years | Percent Change From Baseline in Whole Body BMD at Week 96 | 5.675 percentage change | Standard Deviation 5.1858 |