| Secondary | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. | All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00012.5(NA to NA)Since enough participants could not be enrolled in the Hispanic cohort, 95% CI analysis was only performed on the overall population.
- OG00113.0(3.3 to 22.8)
|
|
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| Secondary | Percentage of Participants With HBV DNA by PCR Category at Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. | All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
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| Secondary | Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV | Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement) | All treated participants. The participants who discontinued prior to Week 48 were counted as failure. | Posted | | Number | | percentage of participants | | through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| |
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L. | All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| |
| Secondary | Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only) | HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| |
| Secondary | Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only) | HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). | Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
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| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 | HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. | All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| |
| Secondary | Percentage of Participants With HBsAg Seroconversion at Week 48 | HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. | All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| |
| Secondary | Mean log10 Reduction From Baseline in HBV DNA at Week 48 | HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load. | All treated participants. The participants who discontinued prior to Week 48 were counted as failure. | Posted | | Mean | Standard Error | log10 IU/mL | | baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
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| Secondary | Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis | | Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks |
| |
| Secondary | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. | All treated participants. | Posted | | Number | | participants | | From enrollment through Week 52 + 5 days | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Hispanic | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG002 | Total | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks |
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| Secondary | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology | Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline. | All treated participants. n = number of participants in the OF period. | Posted | | Number | | participants | | OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
| |
| Primary | Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48 | HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately <300 copies/mL. | All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 of ETV treatment | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
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| Secondary | Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry | The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:>1.25xULN, Aspartate aminotransferase:>1.25xULN, Alkaline Phosphatase:>1.25xULN, Total Bilirubin:>1.1xULN, Serum Lipase:>1.10xULN, Creatinine:>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L | All treated participants. n = number of participants in the OF period. | Posted | | Number | | participants | | OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up | | | | ID | Title | Description |
|---|
| OG000 | Black / African American | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks | | OG001 | Total | Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort) |
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