A Study Evaluating Treatment Intensification With ABI-H07... | NCT04454567

ID	Type	Description	Link
UTN 1111-1251-7136	Other Identifier	World Health Organization

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABI-H0731 + SOC NrtI	Experimental	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).	Drug: ABI-H0731 Drug: NrtI
Placebo + SOC NrtI	Placebo Comparator	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.	Drug: ABI-H0731 Drug: Placebo Drug: NrtI

Name	Type	Description	Arm Group Labels	Other Names
ABI-H0731	Drug	Participants will receive ABI-H0731 tablets orally once daily	ABI-H0731 + SOC NrtI Placebo + SOC NrtI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With an Adverse Event		Baseline and up to 5 months
Number of Participants With Premature Discontinuation of Treatment		Baseline and up to 5 months
Number of Participants With a Laboratory Abnormality		Baseline and up to 5 months
Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48		Week 48

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in log10 HBV DNA		Baseline and up to 5 months
Number of Participants With HBV DNA <LLOQ at Each Timepoint		Baseline and up to 5 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) 18 to 36 kg/m^2 and a minimum body weight of 45 kg (inclusive)
In good general health except for chronic hepatitis B (CHB)
HBeAg positive or HBeAg negative chronic hepatitis B
HBV DNA >LLOQ using a commercially available assay with LLOQ=20 IU/mL
On a stable NrtI regimen (ETV, TDF or TAF) for more than 12 months
Lack of cirrhosis or advanced liver disease

Exclusion Criteria:

Current or prior treatment for CHB with lamivudine, telbivudine, adefovir, HBV core inhibitor, or previous treatment with an investigational agent for HBV infection
Presence of substitutions in the HBV polymerase coding region which may confer reduced susceptibility to NrtIs
Co-infection with human immunodeficiency virus, hepatitis A virus, hepatitis C virus, hepatitis E virus, or hepatitis D virus
Females who are lactating or wish to become pregnant during the course of the trial
History or evidence of advanced liver disease or hepatic decompensation
Clinically significant cardiac disease including poorly-controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than CHB; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment; ongoing infection or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that, in the opinion of the Investigator or the Sponsor, makes the subject unsuitable for trial participation
History of hepatocellular carcinoma (HCC)
Exclusionary laboratory parameters at Screening:
- Platelet count <100,000/mm^3
- Albumin <lower limit of normal
- Total bilirubin >1.2 × upper limit of normal (ULN)
- Direct bilirubin >1.2 × ULN
- ALT >10 × ULN
- Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100 ng/mL, the participant is eligible if a hepatic imaging trial prior to initiation of study drug reveals no lesions indicative of possible HCC.
- International Normalized Ratio >1.5 × ULN
- Glomerular filtration rate <50 mL/min/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration equation
- Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator.

Name	Affiliation	Role
Steven Knox	Assembly Biosciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Asia Pacific Liver Center		Los Angeles	California	90057	United States
California Liver Research Institute

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 8, 2020

Arm/Group Information

ID	Title	Description
BG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
BG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0001 BG0011 BG0022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Hong Kong

Title	Measurements
	BG0001 BG0010 BG002

Years positive for HBV

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0004.6 BG00145 BG002

Years on HBV treatment at Baseline

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0003.6 BG0011.5 BG002

Baseline HBV DNA (Cobas log10 IU/mL)

Mean

Standard Deviation

log10 IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0002.20 BG0012.06 BG002

Baseline HBV pgRNA (log10 U/mL)

Mean

Standard Deviation

log10 U/mL

Title

Denominators

Categories

Title	Measurements
	BG0004.85 BG0016.55 BG002

Baseline HBeAg (log10 IU/mL)

Mean

Standard Deviation

log10 IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0002.35 BG0012.82 BG002

Baseline HBcrAg (log10 kU/mL)

Mean

Standard Deviation

log10 kU/mL

Title

Denominators

Categories

Title	Measurements
	BG0000.89 BG0010.92 BG002

Baseline HBsAg (log10 IU/mL)

Mean

Standard Deviation

log10 IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0003.81 BG0014.61 BG002

Baseline ALT (U/L)

Mean

Standard Deviation

U/L

Title

Denominators

Categories

Title	Measurements
	BG00016 BG00111 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With an Adverse Event

Posted

Number

participants

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Units	Counts
Participants	OG0001 OG0011

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011

Primary

Number of Participants With Premature Discontinuation of Treatment

Posted

Number

participants

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Units	Counts

Primary

Number of Participants With a Laboratory Abnormality

Posted

Number

participants

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Units	Counts

Primary

Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48

Due to early termination of the study, data for Week 48 were not collected and analyzed.

Posted

Week 48

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Mean Change From Baseline in log10 HBV DNA

Due to early termination of the study, data were not collected and analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Number of Participants With HBV DNA <LLOQ at Each Timepoint

Due to early termination of the study, data were not available to analyze the secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Number of Participants With HBV DNA <Limit of Detection (LOD)

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Number of Participants With HBV pgRNA <LLOQ

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Number of Participants With Normalized Alanine Aminotransferase (ALT)

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Plasma Concentrations of ABI-H0731

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Plasma Concentrations of Entecavir

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Secondary

Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment

Due to early termination of the study, data were not analyzed for secondary outcomes.

Posted

Baseline and up to 5 months

ID	Title	Description
OG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
OG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ABI-H0731 + SOC NrtI	Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total). ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert	0	1	0	1	0	1
EG001	Placebo + SOC NrtI	Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120. ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert	0	1	0	1	1	1

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
COVID-19	Infections and infestations		Systematic Assessment	COVID-19 infection	EG0000 affected1 at risk EG0011 events1 affected1 at risk
Flu like symptoms	Injury, poisoning and procedural complications		Systematic Assessment	Flu like symptoms secondary to COVID vaccine	EG0000 affected1 at risk EG0011 events1 affected1 at risk

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms