Trial Outcomes & Findings for Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection (NCT NCT00734162)
NCT ID: NCT00734162
Last Updated: 2016-09-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
Week 72
Results posted on
2016-09-01
Participant Flow
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.
149 participants were screened.
Participant milestones
| Measure |
TDF 12-14 Years
Tenofovir disoproxil fumarate (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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Randomized Phase (Through Week 72)
STARTED
|
10
|
42
|
13
|
41
|
|
Randomized Phase (Through Week 72)
COMPLETED
|
10
|
41
|
13
|
37
|
|
Randomized Phase (Through Week 72)
NOT COMPLETED
|
0
|
1
|
0
|
4
|
|
Open-Label Phase
STARTED
|
10
|
41
|
13
|
39
|
|
Open-Label Phase
COMPLETED
|
7
|
39
|
12
|
36
|
|
Open-Label Phase
NOT COMPLETED
|
3
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
TDF 12-14 Years
Tenofovir disoproxil fumarate (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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
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
|
|
Open-Label Phase
Safety, Tolerability or Efficacy Reasons
|
1
|
0
|
0
|
0
|
|
Open-Label Phase
Withdrew Consent
|
1
|
0
|
1
|
1
|
|
Open-Label Phase
Lost to Follow-up
|
1
|
2
|
0
|
1
|
|
Open-Label Phase
Did Not Meet Entrance Criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
Baseline characteristics by cohort
| Measure |
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 0.82 • n=5 Participants
|
16.1 years
STANDARD_DEVIATION 0.75 • n=7 Participants
|
13.2 years
STANDARD_DEVIATION 0.69 • n=5 Participants
|
15.9 years
STANDARD_DEVIATION 0.82 • n=4 Participants
|
15.4 years
STANDARD_DEVIATION 1.38 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
39 participants
n=7 Participants
|
12 participants
n=5 Participants
|
37 participants
n=4 Participants
|
98 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
31 participants
n=7 Participants
|
6 participants
n=5 Participants
|
31 participants
n=4 Participants
|
74 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Turkey
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
10 participants
n=5 Participants
|
40 participants
n=7 Participants
|
12 participants
n=5 Participants
|
39 participants
n=4 Participants
|
101 participants
n=21 Participants
|
|
Region of Enrollment
North America
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Alanine aminotransferase (ALT) level at baseline
|
77 U/L
STANDARD_DEVIATION 54.8 • n=5 Participants
|
106 U/L
STANDARD_DEVIATION 116.4 • n=7 Participants
|
101 U/L
STANDARD_DEVIATION 95.4 • n=5 Participants
|
101 U/L
STANDARD_DEVIATION 89.5 • n=4 Participants
|
101 U/L
STANDARD_DEVIATION 98.5 • n=21 Participants
|
|
ALT normal at baseline
Normal
|
3 participants
n=5 Participants
|
14 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
ALT normal at baseline
Abnormal
|
7 participants
n=5 Participants
|
28 participants
n=7 Participants
|
9 participants
n=5 Participants
|
33 participants
n=4 Participants
|
77 participants
n=21 Participants
|
|
HBV Genotype
Genotype A
|
5 participants
n=5 Participants
|
30 participants
n=7 Participants
|
5 participants
n=5 Participants
|
29 participants
n=4 Participants
|
69 participants
n=21 Participants
|
|
HBV Genotype
Genotype B
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
HBV Genotype
Genotype C
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HBV Genotype
Genotype D
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
11 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Hepatitis B e Antigen (HBeAg) status at baseline
Negative
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Hepatitis B e Antigen (HBeAg) status at baseline
Positive
|
9 participants
n=5 Participants
|
39 participants
n=7 Participants
|
13 participants
n=5 Participants
|
35 participants
n=4 Participants
|
96 participants
n=21 Participants
|
|
HBV DNA level at baseline
|
8.26 Log_10 copies/mL
STANDARD_DEVIATION 1.455 • n=5 Participants
|
7.95 Log_10 copies/mL
STANDARD_DEVIATION 1.421 • n=7 Participants
|
8.61 Log_10 copies/mL
STANDARD_DEVIATION 1.166 • n=5 Participants
|
8.12 Log_10 copies/mL
STANDARD_DEVIATION 1.451 • n=4 Participants
|
8.13 Log_10 copies/mL
STANDARD_DEVIATION 1.403 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 72Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug
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.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72
|
88.5 percentage of participants
|
0 percentage of participants
|
90.0 percentage of participants
|
88.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 72Population: Safety Analysis Set: participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 96, 144, and 192Population: Full Analysis Set
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192
Week 48
|
86.5 percentage of participants
|
0 percentage of participants
|
90.0 percentage of participants
|
85.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192
Week 96
|
88.5 percentage of participants
|
64.8 percentage of participants
|
90.0 percentage of participants
|
88.1 percentage of participants
|
53.8 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192
Week 144
|
92.3 percentage of participants
|
81.5 percentage of participants
|
100.0 percentage of participants
|
90.5 percentage of participants
|
69.2 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192
Week 192
|
86.5 percentage of participants
|
74.1 percentage of participants
|
90.0 percentage of participants
|
85.7 percentage of participants
|
76.9 percentage of participants
|
73.2 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 72, 96, 144, and 192Population: Full Analysis Set
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
Week 48
|
75.0 percentage of participants
|
27.8 percentage of participants
|
70.0 percentage of participants
|
76.2 percentage of participants
|
30.8 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
Week 72
|
76.9 percentage of participants
|
38.9 percentage of participants
|
80.0 percentage of participants
|
76.2 percentage of participants
|
30.8 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
Week 96
|
76.9 percentage of participants
|
66.7 percentage of participants
|
80.0 percentage of participants
|
76.2 percentage of participants
|
69.2 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
Week 144
|
69.2 percentage of participants
|
74.1 percentage of participants
|
60.0 percentage of participants
|
71.4 percentage of participants
|
69.2 percentage of participants
|
75.6 percentage of participants
|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
Week 192
|
73.1 percentage of participants
|
77.8 percentage of participants
|
80.0 percentage of participants
|
71.4 percentage of participants
|
84.6 percentage of participants
|
75.6 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 72, 96, 144, and 192Population: Full Analysis Set
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
70.0 percentage of participants
|
69.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
80.0 percentage of participants
|
69.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
50.0 percentage of participants
|
80.0 percentage of participants
|
73.8 percentage of participants
|
46.2 percentage of participants
|
51.2 percentage of participants
|
|
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
|
64.8 percentage of participants
|
60.0 percentage of participants
|
69.0 percentage of participants
|
53.8 percentage of participants
|
68.3 percentage of participants
|
|
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
|
64.8 percentage of participants
|
80.0 percentage of participants
|
64.3 percentage of participants
|
69.2 percentage of participants
|
63.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 72, 96, 144, and 192Population: Full Analysis Set
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
Week 48
|
80.8 percentage of participants
|
0 percentage of participants
|
80.0 percentage of participants
|
81.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
Week 72
|
84.6 percentage of participants
|
0 percentage of participants
|
90.0 percentage of participants
|
83.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
Week 96
|
88.5 percentage of participants
|
61.1 percentage of participants
|
90.0 percentage of participants
|
88.1 percentage of participants
|
53.8 percentage of participants
|
63.4 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
Week 144
|
88.5 percentage of participants
|
79.6 percentage of participants
|
90.0 percentage of participants
|
88.1 percentage of participants
|
69.2 percentage of participants
|
82.9 percentage of participants
|
|
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
Week 192
|
84.6 percentage of participants
|
74.1 percentage of participants
|
90.0 percentage of participants
|
83.3 percentage of participants
|
76.9 percentage of participants
|
73.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Full Analysis Set
Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192
Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Full Analysis Set
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.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
Week 72
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
Week 96
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
Week 144
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
Week 192
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 96, 144, and 192Population: Safety Analysis Set
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).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
3.7 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
4.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Safety Analysis Set
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).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=52 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=54 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=42 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=41 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
|
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
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=51 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=49 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=41 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=37 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48
|
3.510 percentage change
Standard Deviation 4.5507
|
5.562 percentage change
Standard Deviation 5.6772
|
9.234 percentage change
Standard Deviation 3.4782
|
2.114 percentage change
Standard Deviation 3.6023
|
9.038 percentage change
Standard Deviation 6.6575
|
4.435 percentage change
Standard Deviation 4.9091
|
SECONDARY outcome
Timeframe: Baseline; Week 72Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=51 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=49 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=41 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=37 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 72
|
5.144 percentage change
Standard Deviation 5.4291
|
8.080 percentage change
Standard Deviation 7.8996
|
11.516 percentage change
Standard Deviation 3.8818
|
3.589 percentage change
Standard Deviation 4.5633
|
14.131 percentage change
Standard Deviation 9.9563
|
6.117 percentage change
Standard Deviation 6.0624
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=50 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=50 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=40 Participants
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
|
Placebo 12-14 Years
n=11 Participants
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
|
Placebo 15-17 Years
n=39 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 96
|
6.119 percentage change
Standard Deviation 6.1200
|
7.003 percentage change
Standard Deviation 9.3658
|
13.811 percentage change
Standard Deviation 4.6712
|
4.196 percentage change
Standard Deviation 4.8021
|
16.687 percentage change
Standard Deviation 10.4359
|
4.272 percentage change
Standard Deviation 7.0463
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=49 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=48 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=10 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 144
|
8.133 percentage change
Standard Deviation 8.5611
|
9.311 percentage change
Standard Deviation 11.3262
|
19.224 percentage change
Standard Deviation 8.7594
|
5.289 percentage change
Standard Deviation 5.8084
|
21.346 percentage change
Standard Deviation 13.4709
|
6.144 percentage change
Standard Deviation 8.3286
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=46 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=46 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=37 Participants
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
|
Placebo 12-14 Years
n=11 Participants
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
|
Placebo 15-17 Years
n=35 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 192
|
10.050 percentage change
Standard Deviation 10.1637
|
11.212 percentage change
Standard Deviation 13.1459
|
23.933 percentage change
Standard Deviation 8.5166
|
6.673 percentage change
Standard Deviation 7.2870
|
25.036 percentage change
Standard Deviation 14.2346
|
6.867 percentage change
Standard Deviation 9.3736
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=48 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=50 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=37 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Whole Body BMD at Week 48
|
2.048 percentage change
Standard Deviation 2.7830
|
3.817 percentage change
Standard Deviation 3.1576
|
5.123 percentage change
Standard Deviation 3.8309
|
1.339 percentage change
Standard Deviation 1.9324
|
5.470 percentage change
Standard Deviation 3.4958
|
3.236 percentage change
Standard Deviation 2.8573
|
SECONDARY outcome
Timeframe: Baseline; Week 72Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=50 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=51 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=41 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Whole Body BMD at Week 72
|
3.067 percentage change
Standard Deviation 3.4819
|
5.391 percentage change
Standard Deviation 4.0902
|
7.282 percentage change
Standard Deviation 3.9156
|
2.141 percentage change
Standard Deviation 2.6284
|
8.480 percentage change
Standard Deviation 4.4770
|
4.335 percentage change
Standard Deviation 3.4073
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=49 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=50 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=40 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Whole Body BMD at Week 96
|
3.943 percentage change
Standard Deviation 3.7730
|
5.675 percentage change
Standard Deviation 5.1858
|
8.034 percentage change
Standard Deviation 3.4973
|
3.023 percentage change
Standard Deviation 3.2063
|
10.056 percentage change
Standard Deviation 5.4296
|
4.291 percentage change
Standard Deviation 4.3195
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=47 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=49 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=38 Participants
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
|
Placebo 12-14 Years
n=11 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Whole Body BMD at Week 144
|
4.949 percentage change
Standard Deviation 4.5753
|
6.505 percentage change
Standard Deviation 6.2944
|
10.940 percentage change
Standard Deviation 4.8819
|
3.529 percentage change
Standard Deviation 3.1734
|
12.638 percentage change
Standard Deviation 5.9973
|
4.730 percentage change
Standard Deviation 5.2213
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=43 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=46 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=8 Participants
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
|
TDF 15-17 Years
n=35 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=34 Participants
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
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Whole Body BMD at Week 192
|
6.086 percentage change
Standard Deviation 5.4029
|
7.223 percentage change
Standard Deviation 7.2666
|
13.923 percentage change
Standard Deviation 4.6139
|
4.295 percentage change
Standard Deviation 3.7318
|
14.797 percentage change
Standard Deviation 6.4993
|
4.549 percentage change
Standard Deviation 5.4494
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
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).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=51 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=49 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=41 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=37 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Spine BMD at Week 48
|
-0.08 z-score
Standard Deviation 0.256
|
0.05 z-score
Standard Deviation 0.337
|
0.02 z-score
Standard Deviation 0.247
|
-0.10 z-score
Standard Deviation 0.255
|
0.04 z-score
Standard Deviation 0.393
|
0.05 z-score
Standard Deviation 0.322
|
SECONDARY outcome
Timeframe: Baseline; Week 72Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=51 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=49 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=41 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=37 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Spine BMD at Week 72
|
-0.06 z-score
Standard Deviation 0.320
|
0.10 z-score
Standard Deviation 0.378
|
-0.10 z-score
Standard Deviation 0.312
|
-0.05 z-score
Standard Deviation 0.325
|
0.09 z-score
Standard Deviation 0.498
|
0.10 z-score
Standard Deviation 0.339
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=50 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=50 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=40 Participants
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
|
Placebo 12-14 Years
n=11 Participants
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
|
Placebo 15-17 Years
n=39 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Spine BMD at Week 96
|
-0.10 z-score
Standard Deviation 0.357
|
-0.11 z-score
Standard Deviation 0.431
|
-0.19 z-score
Standard Deviation 0.365
|
-0.07 z-score
Standard Deviation 0.356
|
-0.02 z-score
Standard Deviation 0.498
|
-0.13 z-score
Standard Deviation 0.414
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=49 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=48 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=10 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=10 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Spine BMD at Week 144
|
-0.08 z-score
Standard Deviation 0.447
|
-0.06 z-score
Standard Deviation 0.455
|
-0.20 z-score
Standard Deviation 0.560
|
-0.05 z-score
Standard Deviation 0.417
|
-0.16 z-score
Standard Deviation 0.625
|
-0.04 z-score
Standard Deviation 0.405
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=46 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=46 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=37 Participants
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
|
Placebo 12-14 Years
n=11 Participants
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
|
Placebo 15-17 Years
n=35 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Spine BMD at Week 192
|
0.02 z-score
Standard Deviation 0.548
|
-0.10 z-score
Standard Deviation 0.543
|
-0.24 z-score
Standard Deviation 0.518
|
0.08 z-score
Standard Deviation 0.544
|
-0.26 z-score
Standard Deviation 0.654
|
-0.05 z-score
Standard Deviation 0.504
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=48 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=50 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=37 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Whole Body BMD at Week 48
|
-0.12 z-score
Standard Deviation 0.298
|
0.05 z-score
Standard Deviation 0.322
|
0.02 z-score
Standard Deviation 0.426
|
-0.15 z-score
Standard Deviation 0.257
|
0.10 z-score
Standard Deviation 0.370
|
0.04 z-score
Standard Deviation 0.308
|
SECONDARY outcome
Timeframe: Baseline; Week 72Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=50 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=51 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=41 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Whole Body BMD at Week 72
|
-0.16 z-score
Standard Deviation 0.355
|
0.09 z-score
Standard Deviation 0.349
|
0.02 z-score
Standard Deviation 0.398
|
-0.19 z-score
Standard Deviation 0.338
|
0.20 z-score
Standard Deviation 0.450
|
0.06 z-score
Standard Deviation 0.306
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=49 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=50 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=40 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Whole Body BMD at Week 96
|
-0.18 z-score
Standard Deviation 0.424
|
-0.03 z-score
Standard Deviation 0.456
|
-0.12 z-score
Standard Deviation 0.294
|
-0.19 z-score
Standard Deviation 0.451
|
0.09 z-score
Standard Deviation 0.528
|
-0.06 z-score
Standard Deviation 0.432
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=47 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=49 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=38 Participants
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
|
Placebo 12-14 Years
n=11 Participants
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
|
Placebo 15-17 Years
n=38 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Whole Body BMD at Week 144
|
-0.22 z-score
Standard Deviation 0.462
|
-0.14 z-score
Standard Deviation 0.484
|
-0.27 z-score
Standard Deviation 0.431
|
-0.21 z-score
Standard Deviation 0.473
|
-0.06 z-score
Standard Deviation 0.554
|
-0.16 z-score
Standard Deviation 0.468
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Safety Analysis Set with available data were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis).
Outcome measures
| Measure |
Total TDF 12-17 Years
n=43 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=46 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=8 Participants
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
|
TDF 15-17 Years
n=35 Participants
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
|
Placebo 12-14 Years
n=12 Participants
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
|
Placebo 15-17 Years
n=34 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Z-score for Whole Body BMD at Week 192
|
-0.16 z-score
Standard Deviation 0.521
|
-0.19 z-score
Standard Deviation 0.504
|
-0.34 z-score
Standard Deviation 0.499
|
-0.11 z-score
Standard Deviation 0.524
|
-0.21 z-score
Standard Deviation 0.486
|
-0.19 z-score
Standard Deviation 0.517
|
SECONDARY outcome
Timeframe: Baseline through Week 192Population: 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.
The number of participants with changes in drug-resistant mutations during the study was summarized.
Outcome measures
| Measure |
Total TDF 12-17 Years
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=52 Participants
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
|
TDF 15-17 Years
n=54 Participants
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
|
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
|
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
|
|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Drug-Resistant Mutations During the Study
New TDF Drug-Resistant Mutations
|
—
|
—
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Changes in Drug-Resistant Mutations During the Study
Enrichment of TDF Drug-Resistant Mutations
|
—
|
—
|
0 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=48 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=48 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=35 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
8.3 percentage of participants
|
11.1 percentage of participants
|
17.9 percentage of participants
|
7.7 percentage of participants
|
8.6 percentage of participants
|
|
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
|
14.6 percentage of participants
|
11.1 percentage of participants
|
23.1 percentage of participants
|
23.1 percentage of participants
|
11.4 percentage of participants
|
|
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
|
31.3 percentage of participants
|
44.4 percentage of participants
|
30.8 percentage of participants
|
38.5 percentage of participants
|
28.6 percentage of participants
|
|
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
|
39.6 percentage of participants
|
44.4 percentage of participants
|
38.5 percentage of participants
|
53.8 percentage of participants
|
34.3 percentage of participants
|
|
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
|
41.7 percentage of participants
|
33.3 percentage of participants
|
43.6 percentage of participants
|
53.8 percentage of participants
|
37.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=48 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=48 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=35 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
8.3 percentage of participants
|
11.1 percentage of participants
|
15.4 percentage of participants
|
7.7 percentage of participants
|
8.6 percentage of participants
|
|
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
|
14.6 percentage of participants
|
11.1 percentage of participants
|
23.1 percentage of participants
|
23.1 percentage of participants
|
11.4 percentage of participants
|
|
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
|
29.2 percentage of participants
|
44.4 percentage of participants
|
30.8 percentage of participants
|
38.5 percentage of participants
|
25.7 percentage of participants
|
|
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
|
39.6 percentage of participants
|
33.3 percentage of participants
|
38.5 percentage of participants
|
53.8 percentage of participants
|
34.3 percentage of participants
|
|
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
|
41.7 percentage of participants
|
33.3 percentage of participants
|
38.5 percentage of participants
|
53.8 percentage of participants
|
37.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=48 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=48 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=9 Participants
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
|
TDF 15-17 Years
n=39 Participants
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
|
Placebo 12-14 Years
n=13 Participants
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
|
Placebo 15-17 Years
n=35 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
11.1 percentage of participants
|
12.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
11.1 percentage of participants
|
15.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
25.0 percentage of participants
|
44.4 percentage of participants
|
28.2 percentage of participants
|
30.8 percentage of participants
|
22.9 percentage of participants
|
|
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
|
31.3 percentage of participants
|
22.2 percentage of participants
|
30.8 percentage of participants
|
46.2 percentage of participants
|
25.7 percentage of participants
|
|
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
|
31.3 percentage of participants
|
33.3 percentage of participants
|
28.2 percentage of participants
|
46.2 percentage of participants
|
25.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=35 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=42 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=7 Participants
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
|
TDF 15-17 Years
n=28 Participants
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
|
Placebo 12-14 Years
n=9 Participants
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
|
Placebo 15-17 Years
n=33 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
19.0 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
11.1 percentage of participants
|
21.2 percentage of participants
|
|
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
|
31.0 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
22.2 percentage of participants
|
33.3 percentage of participants
|
|
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
|
64.3 percentage of participants
|
85.7 percentage of participants
|
78.6 percentage of participants
|
66.7 percentage of participants
|
63.6 percentage of participants
|
|
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
|
71.4 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
66.7 percentage of participants
|
72.7 percentage of participants
|
|
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
|
71.4 percentage of participants
|
85.7 percentage of participants
|
75.0 percentage of participants
|
77.8 percentage of participants
|
69.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=35 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=42 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=7 Participants
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
|
TDF 15-17 Years
n=28 Participants
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
|
Placebo 12-14 Years
n=9 Participants
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
|
Placebo 15-17 Years
n=33 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
85.7 percentage of participants
|
71.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
54.8 percentage of participants
|
85.7 percentage of participants
|
78.6 percentage of participants
|
55.6 percentage of participants
|
54.5 percentage of participants
|
|
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
|
69.0 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
66.7 percentage of participants
|
69.7 percentage of participants
|
|
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
|
61.9 percentage of participants
|
85.7 percentage of participants
|
67.9 percentage of participants
|
77.8 percentage of participants
|
57.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192Population: Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.
Outcome measures
| Measure |
Total TDF 12-17 Years
n=33 Participants
TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
Total Placebo 12-17 Years
n=42 Participants
TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
|
TDF 12-14 Years
n=6 Participants
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
|
TDF 15-17 Years
n=27 Participants
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
|
Placebo 12-14 Years
n=9 Participants
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
|
Placebo 15-17 Years
n=33 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
0 percentage of participants
|
16.7 percentage of participants
|
18.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
16.7 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
26.2 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
24.2 percentage of participants
|
|
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
|
33.3 percentage of participants
|
33.3 percentage of participants
|
29.6 percentage of participants
|
55.6 percentage of participants
|
27.3 percentage of participants
|
|
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
|
33.3 percentage of participants
|
50.0 percentage of participants
|
29.6 percentage of participants
|
55.6 percentage of participants
|
27.3 percentage of participants
|
Adverse Events
Double-Blind TDF
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Double-Blind Placebo
Serious events: 11 serious events
Other events: 40 other events
Deaths: 0 deaths
Open-Label TDF-TDF
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
Open-Label Placebo-TDF
Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind TDF
n=52 participants at risk
Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
|
Double-Blind Placebo
n=54 participants at risk
Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
|
Open-Label TDF-TDF
n=51 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
|
Open-Label Placebo-TDF
n=52 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastroduodenitis
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Hepatobiliary disorders
Hepatitis
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
13.0%
7/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Appendicitis
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Blood creatinine increased
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Glucose urine present
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Protein urine present
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
Other adverse events
| Measure |
Double-Blind TDF
n=52 participants at risk
Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
|
Double-Blind Placebo
n=54 participants at risk
Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
|
Open-Label TDF-TDF
n=51 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
|
Open-Label Placebo-TDF
n=52 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
9.3%
5/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
13.0%
7/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
17.3%
9/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
4/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.9%
3/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
General disorders
Pyrexia
|
7.7%
4/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
11.8%
6/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
7.7%
4/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.7%
2/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
9.6%
5/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
5/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
22.2%
12/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
11.8%
6/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
23.1%
12/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Pharyngitis
|
28.8%
15/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
20.4%
11/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
17.6%
9/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
25.0%
13/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.7%
2/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Rhinitis
|
9.6%
5/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.9%
3/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Tonsillitis
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
7.4%
4/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.9%
2/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
7.7%
4/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
5/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
13.0%
7/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.9%
3/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
13.5%
7/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Infections and infestations
Viral infection
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
7.8%
4/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Contusion
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
9.3%
5/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Investigations
Blood creatine phosphokinase increased
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.9%
2/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
16.7%
9/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
2.0%
1/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
7.4%
4/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
5.6%
3/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.7%
2/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
9.3%
5/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
1.9%
1/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.8%
2/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
18.5%
10/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
3.9%
2/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
11.5%
6/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.8%
3/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/54 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/51 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
0.00%
0/52 • Baseline through end of the Open-Label Phase (up to 4 years)
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER