| Primary | Percentage of Participants Who Achieved a Virologic Response at Week 24 | Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay. | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Percentage of participants | | At Week 24 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| | 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 |
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| A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir. | Chi-squared | | 0.0006 | There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established. | Difference in proportion | 25.67 | | | 2-Sided | 90 | 14.48 | 36.86 | | | | Yes | Non-Inferiority or Equivalence | The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero. |
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| Secondary | Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96 | The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint. | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Participants | | At Weeks 24, 48, and 96 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240 | Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay. | Randomized participants who received at least 1 dose of study drug | Posted | | Mean | Standard Deviation | log10 copies/mL | | At Weeks 24, 48, 96, 144, 192, and 240 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg+ Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24 | Mean ALT values from baseline by laboratory test. . | Randomized participants who received at least 1 dose of study drug | Posted | | Mean | Standard Deviation | U/L | | At Week 24 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96 | Normalization of serum ALT= ≤*institutional upper limit of normal. | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Participants | | At Weeks 24, 48, and 96 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status. | Treated cohort: includes participants who are randomized and received at least 1 dose of study drug (ETV or LVD). | Posted | | Number | | Participants | | Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24 | ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status. | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Participants | | Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24 | ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment). | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Participants | | Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24 | Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate. | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Participants | | Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Virologic Rebound at Week 24 | Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement). | | Posted | | Number | | Participants | | At Week 24 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg | Participants received lamivudine, 100 mg, once daily for up to 240 weeks |
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| Secondary | Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240 | Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay | Randomized participants who received at least 1 dose of study drug | Posted | | Number | | Percetage of participants | | At Weeks 48, 96, 144, 192, and 240 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96 | Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement). | All participants who received study drug and who had samples of measureable HBV DNA values | Posted | | Number | | Participants | | At 96 weeks | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | Participants who were randomized and received at least 1 dose of study drug | Posted | | Number | | Participants | | Start of dosing (Day 1) until end of treatment (Week 240) + 5 days | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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| Secondary | Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96 | ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment). | Randomized participants who received at least 1 dose of study drug and who were evaluable. | Posted | | Number | | Participants | | Start of dosing (Day 1) until Week 96 | | | | ID | Title | Description |
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| OG000 | Entecavir, 0.5 mg + Placebo | Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). | | OG001 | Lamivudine, 100 mg + Placebo | Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period). |
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