| Primary | Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV | Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL. | Intent-to-treat (ITT) population: all randomized participants | Posted | | Mean | Standard Deviation | Log10 International Units (IU)/mL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
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| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG0007.91± 0.890
- OG0018.03± 0.999
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| | Change from Baseline at Week 12 | | |
| | 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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| Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12 | Repeated measures analysis | | 0.0077 | | LS Mean Difference | -1.154 | | | 2-Sided | 95 | -1.986 | -0.322 | | | | | Other | | | | Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24 |
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| Secondary | Number of Participants One or More Adverse Events | | Safety population: all randomized participants who received any amount of study drug | Posted | | Count of Participants | | Participants | | Up to Follow-up (maximum up to Week 36) | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
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| Secondary | Number of Participants With Premature Study Discontinuation | | | Posted | | Count of Participants | | Participants | | Up to Follow-up (maximum up to Week 36) | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
| |
| Secondary | Number of Participants With One or More Abnormal Safety Laboratory Result | | Safety population: all randomized participants who received any amount of study drug | Posted | | Count of Participants | | Participants | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
| |
| Secondary | Number of Participants With a Clinically-significant Electrocardiogram Abnormality | | Safety population: all randomized participants who received any amount of study drug | Posted | | Count of Participants | | Participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
| |
| Secondary | Number of Participants With a Clinically-significant Change in Vital Signs | Vital signs assessed were body temperature, respiratory rate, and pulse rate | Safety population: all randomized participants who received any amount of study drug | Posted | | Count of Participants | | Participants | | Baseline and up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
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| Secondary | Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | | Participants in the ITT population with abnormal ALT at Baseline | Posted | | Count of Participants | | Participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
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| Secondary | Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (<20 IU/mL) and target detected (≥10 IU/mL) was assessed. | ITT population and had viral DNA data available | Posted | | Count of Participants | | Participants | | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
|
| Secondary | Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV | Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV. | Median time to viral suppression could not be calculated because fewer than 50% of participants achieved viral suppression within 24 weeks. | Posted | | | | | | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
|
| Secondary | Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV | Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA. | | Posted | | Count of Participants | | Participants | | Up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
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| Secondary | Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy | | Results were analyzed and reported only for participants in the safety population who received ABI-H0731 + SOC ETV and had ABI-H0731 pharmacokinetic data assessments available. | Posted | | Mean | Standard Deviation | ng/mL | | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. |
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| Secondary | Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | | Results were analyzed and reported only for participants in the safety population who had ETV pharmacokinetic data assessments available. | Posted | | Mean | Standard Deviation | ng/mL | | Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
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| Secondary | Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy | | Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples. | Posted | | | | | | Baseline, Weeks 2, 4, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. |
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| Secondary | Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy | | Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples. | Posted | | | | | | Baseline, Weeks 2, 4, 12, 24, and 28 | | | | ID | Title | Description |
|---|
| OG000 | ABI-H0731 + SOC ETV | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. ABI-H0731: Participants will receive 300mg QD of ABI-H0731 tablets orally. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. | | OG001 | Placebo + SOC ETV | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally. |
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