| Primary | Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach) | | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00076.7(64.0 to 86.6)
- OG0016.9(0.8 to 22.8)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | 2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata | < 0.001 | | | | | | | | | | | | | | Superiority | | | | | Fisher Exact | |
|
| Secondary | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 | HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | 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 | Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range | Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range | 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. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range | 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. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range | 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. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range | 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. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
|
| Secondary | Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range | 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. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range | 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. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
|
| Secondary | 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 | 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. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | 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 | 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. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
|
| Secondary | 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 | 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. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | 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 | 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. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
|
| Secondary | Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48 | | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192 | | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | Percentage of Participants With HBsAg Loss at Week 48 | HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With HBsAg Loss at Week 192 | HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | Percentage of Participants With HBsAg Seroconversion at Week 48 | HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive. | 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. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With HBsAg Seroconversion at Week 192 | HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive. | 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. | Posted | | Number | | percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | 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 | | Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 48 were analyzed. | Posted | | Count of Participants | | Participants | No | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | 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 | | Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 96 were analyzed. | Posted | | Count of Participants | | Participants | No | Baseline; Week 96 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | 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 | | Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 144 were analyzed. | Posted | | Count of Participants | | Participants | No | Baseline; Week 144 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | 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 | | Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 192 were analyzed. | Posted | | Count of Participants | | Participants | No | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48 | | 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. | Posted | | Number | | percentage of participants | | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192 | | Participants in the Spine DXA Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
| |
| Secondary | Percent Change From Baseline in BMD of Spine at Week 48 | | Participants in the Spine DXA Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Percent change in spine BMD | | Baseline; Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
| |
| Secondary | Percent Change From Baseline in BMD of Spine at Week 192 | | Participants in the Spine DXA Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Percent change in spine BMD | | Baseline; Week 192 | | | | ID | Title | Description |
|---|
| OG000 | TDF to TDF | 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). | | OG001 | Placebo to TDF | 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). |
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| Primary | Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach) | | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | TDF (Blinded Randomized Phase) | 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) | | OG001 | Placebo (Blinded Randomized Phase) | Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) |
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