Trial Outcomes & Findings for Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection (NCT NCT01651403)
NCT ID: NCT01651403
Last Updated: 2026-01-30
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Week 48
Results posted on
2026-01-30
Participant Flow
Participants were enrolled at study sites in the United States, Asia, and Europe.The first participant was screened on 06 December 2012. The last Week 192 study visit occurred on 02 June 2020.
176 participants were screened.
Participant milestones
| Measure |
Tenofovir Disoproxil Fumarate
Blinded Randomized Phase: Tenofovir disoproxil fumarate (TDF) tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
Placebo
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
|---|---|---|
|
Double-Blind Period (Through Week 48/72)
STARTED
|
60
|
30
|
|
Double-Blind Period (Through Week 48/72)
COMPLETED
|
56
|
25
|
|
Double-Blind Period (Through Week 48/72)
NOT COMPLETED
|
4
|
5
|
|
Open-Label Phase (Weeks 49/73-192)
STARTED
|
56
|
25
|
|
Open-Label Phase (Weeks 49/73-192)
COMPLETED
|
35
|
11
|
|
Open-Label Phase (Weeks 49/73-192)
NOT COMPLETED
|
21
|
14
|
Reasons for withdrawal
| Measure |
Tenofovir Disoproxil Fumarate
Blinded Randomized Phase: Tenofovir disoproxil fumarate (TDF) tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
Placebo
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
|---|---|---|
|
Double-Blind Period (Through Week 48/72)
Participant Noncompliance
|
1
|
1
|
|
Double-Blind Period (Through Week 48/72)
Withdrew Consent/Assent
|
3
|
3
|
|
Double-Blind Period (Through Week 48/72)
Randomized but not Treated
|
0
|
1
|
|
Open-Label Phase (Weeks 49/73-192)
Continuing Study
|
13
|
9
|
|
Open-Label Phase (Weeks 49/73-192)
Investigator decision
|
2
|
1
|
|
Open-Label Phase (Weeks 49/73-192)
Withdrew consent/assent
|
6
|
4
|
Baseline Characteristics
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
Baseline characteristics by cohort
| Measure |
Tenofovir Disoproxil Fumarate
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
Placebo
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6 years
STANDARD_DEVIATION 2.5 • n=35 Participants
|
7 years
STANDARD_DEVIATION 3.2 • n=4328 Participants
|
6 years
STANDARD_DEVIATION 2.8 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=35 Participants
|
12 Participants
n=4328 Participants
|
39 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=35 Participants
|
17 Participants
n=4328 Participants
|
50 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=35 Participants
|
29 Participants
n=4328 Participants
|
89 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Asian
|
41 Participants
n=35 Participants
|
17 Participants
n=4328 Participants
|
58 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=35 Participants
|
11 Participants
n=4328 Participants
|
26 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Region of Enrollment
South Korea
|
23 Participants
n=35 Participants
|
11 Participants
n=4328 Participants
|
34 Participants
n=8687 Participants
|
|
Region of Enrollment
Romania
|
13 Participants
n=35 Participants
|
10 Participants
n=4328 Participants
|
23 Participants
n=8687 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
17 Participants
n=8687 Participants
|
|
Region of Enrollment
Taiwan
|
2 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
|
Region of Enrollment
India
|
8 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
13 Participants
n=8687 Participants
|
|
HBV DNA
|
8.089 log10 IU/mL
STANDARD_DEVIATION 0.7208 • n=35 Participants
|
8.133 log10 IU/mL
STANDARD_DEVIATION 1.2538 • n=4328 Participants
|
8.103 log10 IU/mL
STANDARD_DEVIATION 0.9214 • n=8687 Participants
|
|
Hepatitis B Virus Surface Antigen (HBsAg)
Positive
|
60 Participants
n=35 Participants
|
29 Participants
n=4328 Participants
|
89 Participants
n=8687 Participants
|
|
Hepatitis B Virus Surface Antigen (HBsAg)
Negative
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Hepatitis B e antigen (HBeAg)
Positive
|
56 Participants
n=35 Participants
|
29 Participants
n=4328 Participants
|
85 Participants
n=8687 Participants
|
|
Hepatitis B e antigen (HBeAg)
Negative
|
4 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
HBeAb
Positive
|
4 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
HBeAb
Negative or Missing
|
56 Participants
n=35 Participants
|
29 Participants
n=4328 Participants
|
85 Participants
n=8687 Participants
|
|
Spine Bone Mineral Density
|
0.586 g/cm^2
STANDARD_DEVIATION 0.1196 • n=35 Participants
|
0.626 g/cm^2
STANDARD_DEVIATION 0.1567 • n=4328 Participants
|
0.599 g/cm^2
STANDARD_DEVIATION 0.1332 • n=8687 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Full Analysis Set (FAS) included randomized participants who have received at least 1 dose of study drug. Participants will be analyzed according to the treatment to which they were randomized. The missing equals failure approach was used where all participants with missing data were considered to have failed to achieve the endpoint.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
|
76.7 percentage of participants
Interval 64.0 to 86.6
|
6.9 percentage of participants
Interval 0.8 to 22.8
|
PRIMARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with available data were analyzed. The missing equals failure approach was used where all participants with missing data were excluded.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=55 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=26 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
|
83.6 percentage of participants
Interval 71.2 to 92.2
|
7.7 percentage of participants
Interval 0.9 to 25.1
|
SECONDARY outcome
Timeframe: Week 48Population: Serologically Evaluable FAS For HBeAg loss/seroconversion: participants who were randomized and had received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=56 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
|
25.0 percentage of participants
|
24.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range
|
51.7 percentage of participants
|
17.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
|
71.7 percentage of participants
|
51.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
|
65.0 percentage of participants
|
17.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
|
80.0 percentage of participants
|
62.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=28 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
|
51.7 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=28 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
|
71.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=58 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=27 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
|
65.5 percentage of participants
|
14.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=58 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=27 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
|
79.3 percentage of participants
|
59.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=28 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48
|
46.7 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=28 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192
|
70.0 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=58 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=27 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48
|
53.4 percentage of participants
|
7.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=58 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=27 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192
|
75.9 percentage of participants
|
55.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
|
71.7 percentage of participants
|
6.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
|
81.7 percentage of participants
|
62.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With HBsAg Loss at Week 48
|
3.3 percentage of participants
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With HBsAg Loss at Week 192
|
10.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion at Week 48
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Population: Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion at Week 192
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 48 were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=10 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=26 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 96 were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=5 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=12 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 144 were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=4 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=1 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 192 were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=2 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=2 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Spine Dual X-Ray Absorptiometry (DXA) Analysis Set: all randomized participants who received at least 1 dose of study drug and had nonmissing baseline spine bone mineral density values.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
|
18.3 percentage of participants
|
6.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Spine DXA Analysis Set were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=60 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
|
18.3 percentage of participants
|
6.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=55 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=25 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percent Change From Baseline in BMD of Spine at Week 48
|
3.798 Percent change in spine BMD
Standard Deviation 5.9118
|
7.557 Percent change in spine BMD
Standard Deviation 4.9790
|
SECONDARY outcome
Timeframe: Baseline; Week 192Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TDF (Blinded Randomized Phase)
n=52 Participants
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=18 Participants
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
|---|---|---|
|
Percent Change From Baseline in BMD of Spine at Week 192
|
19.168 Percent change in spine BMD
Standard Deviation 12.2805
|
26.085 Percent change in spine BMD
Standard Deviation 14.2586
|
Adverse Events
TDF (Blinded Randomized Phase)
Serious events: 10 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo (Blinded Randomized Phase)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
TDF to TDF (Open-Label Phase)
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo to TDF (Open-Label Phase)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDF (Blinded Randomized Phase)
n=60 participants at risk
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 participants at risk
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
TDF to TDF (Open-Label Phase)
n=56 participants at risk
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
Placebo to TDF (Open-Label Phase)
n=25 participants at risk
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
|---|---|---|---|---|
|
Infections and infestations
Acute hepatitis B
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
4/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Investigations
Hepatic enzyme increased
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Encephalopathy
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.7%
1/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
Other adverse events
| Measure |
TDF (Blinded Randomized Phase)
n=60 participants at risk
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
Placebo (Blinded Randomized Phase)
n=29 participants at risk
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
|
TDF to TDF (Open-Label Phase)
n=56 participants at risk
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
Placebo to TDF (Open-Label Phase)
n=25 participants at risk
Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
8.0%
2/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Pyrexia
|
15.0%
9/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
6.9%
2/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
7.1%
4/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Ear infection
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
9/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
6.9%
2/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
21.4%
12/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Otitis media
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
1.8%
1/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pharyngitis
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
10.3%
3/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.6%
2/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Tonsillitis
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
9/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
17.2%
5/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
5.4%
3/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
12.0%
3/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Varicella
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
3/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
10.3%
3/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Headache
|
3.3%
2/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
6.9%
2/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.6%
2/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
5/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
3.4%
1/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
4.0%
1/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/60 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
6.9%
2/29 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/56 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/25 • First dose date up to the Week 192 Data Cut for Open-Label Phase; Additional adverse event data will be reported after study is completed and final analysis is done.
Safety Analysis all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase. All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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