Study to Evaluate the Safety, Tolerability, and Antiviral... | NCT03615066

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Selgantolimod 3 mg + TAF	Experimental	Participants with Hepatitis B e antigen (HBeAg)-positive CHB or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, will receive selgantolimod 3 mg (2 x 1.5 mg tablet) on the same day once weekly for 24 doses along with tenofovir alafenamide (TAF) 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Drug: Selgantolimod Drug: TAF
Selgantolimod 1.5 mg + TAF	Experimental	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, selgantolimod will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Drug: Placebo Drug: Selgantolimod Drug: TAF
Placebo + TAF	Placebo Comparator	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, will receive 2 tablets of placebo on the same day once weekly for 24 doses along with TAF 25 mg once daily for 24 weeks. After the 24th dose, placebo will be discontinued, and participants will continue to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Tablet(s) administered orally every 7 days for 24 doses in fasted state	Placebo + TAF Selgantolimod 1.5 mg + TAF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24		Baseline, Week 24
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as any AE with an onset date on or after the first dose date and no later than 30 days after permanent discontinuation of selgantolimod/placebo; or any AE leading to premature discontinuation of study drugs.	First dose date up to Week 24 plus 30 days
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities	Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 30 days for selgantolimod/placebo at Week 24. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Clinical laboratory results were graded according to Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.	First dose date up to Week 24 plus 30 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4		Baseline, Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8		Baseline, Week 8

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary Liver Unit - Heritage Medical Research Clinic		Calgary	Alberta	T2N4Z6	Canada

PubMed Identifier	Type	Citation	Retractions
	Background	Chen D, Kim S, Brooks A, McDonald C, Yang J, Gaggar A, et al. Potential Biomarkers of Response in Chronic Hepatitis B Patients Who Achieved HBeAg Loss Upon Treatment With Toll-Like Receptor 8 Agonist Selgantolimod [Poster]. The Digital International Liver Conference 2020 27-29 August.
	Background	Janssen H, Lampertico P, Chen C-Y, Heo J, Foumier C, Ahn S, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster]. The Digital International Liver Conference 2020 27-29 August.
	Background	Janssen H, Lim Y-S, Kim HJ, Tseng C-H, Coffin C, Elkashab M, et al. Safety and Efficacy of Oral TLR8 Agonist Selgantolimod in Viremic Adult Patients With Chronic Hepatitis B [Poster]. International Liver Congress 2021 23-26 June.

ID	Title	Description
FG000	Selgantolimod 3 mg + TAF	Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) or HBeAg-negative CHB currently not on oral antiviral (OAV) treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the tenofovir alafenamide (TAF) 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 27, 2019	Oct 30, 2020

Arm/Group Information

ID	Title	Description
BG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
BG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
BG002	Placebo + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
BG003	Total	Total of all reporting groups

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

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24

The Full Analysis Set included all randomized participants who took at least 1 dose of the study drug.

Posted

Number

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Units	Counts
Participants	OG00026 OG00128 OG00213

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020

Primary

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as any AE with an onset date on or after the first dose date and no later than 30 days after permanent discontinuation of selgantolimod/placebo; or any AE leading to premature discontinuation of study drugs.

The Safety Analysis Set included all participants who took at least 1 dose of the study drug.

Posted

Number

percentage of participants

First dose date up to Week 24 plus 30 days

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 doses. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Primary

Percentage of Participants With Treatment-Emergent Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 30 days for selgantolimod/placebo at Week 24. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Clinical laboratory results were graded according to Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.

Participants in the Safety Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to Week 24 plus 30 days

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline, Week 4

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline, Week 8

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline, Week 12

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline, Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Change From Baseline in Serum qHBsAg at Week 4

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 4

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Change From Baseline in Serum qHBsAg at Week 8

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 8

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Change From Baseline in Serum qHBsAg at Week 12

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 12

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Change From Baseline in Serum qHBsAg at Week 24

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 24

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Change From Baseline in Serum qHBsAg at Week 48

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < Lower Limit of Quantification (LLOQ) at Week 12

LLOQ was defined as 20 IU/mL.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With HBV DNA < LLOQ at Week 24

LLOQ was defined as 20 IU/mL.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Percentage of Participants With HBV DNA < LLOQ at Week 48

LLOQ was defined as 20 IU/mL.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With HBsAg Loss at Week 24

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With HBsAg Loss at Week 48

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With HBeAg Loss and Seroconversion at Week 12

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as Hepatitis B e antibody (HBeAb) loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.

Participants in the Full Analysis Set with available data were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF: HBeAg-positive CHB Participants	Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF: HBeAg-positive CHB Participants	Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With HBeAg Loss and Seroconversion at Week 24

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb loss and anti-HBe change from negative/missing at baseline to positive at a postbaseline visit.

Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF: HBeAg-positive CHB Participants	Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF: HBeAg-positive CHB Participants	Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With HBeAg Loss and Seroconversion at Week 48

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

Participants in the Full Analysis Set with available data were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF: HBeAg-positive CHB Participants	Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF: HBeAg-positive CHB Participants	Participants with HBeAg-positive CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With Virologic Breakthrough From Baseline up to Week 24

Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline up to Week 24

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With Virologic Breakthrough From Baseline up to Week 48

Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline up to Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

Percentage of Participants With Drug Resistance Mutations

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Baseline up to Week 48

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG002	Placebo + TAF

Secondary

Pharmacokinetic (PK) Parameter: AUClast of Selgantolimod

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Participants in the PK Substudy Analysis Set (all randomized participants who took at least 1 dose of the study drug, participated in the optional intensive PK substudy, and had at least 1 nonmissing postdose concentration) with available data were analyzed.

Posted

Mean

Standard Deviation

hr*pg/mL

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

PK Parameter: AUC0-24 of Selgantolimod

AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.

Participants in the PK Substudy Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

hr*pg/mL

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

PK Parameter: AUCinf of Selgantolimod

AUC0-inf is defined as the concentration of drug over time from time zero to infinity.

Participants in the PK Substudy Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

hr*pg/mL

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

PK Parameter: Cmax of Selgantolimod

Cmax is defined as the maximum concentration of drug.

Participants in the PK Substudy Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

pg/mL

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

PK Parameter: Tmax of Selgantolimod

Tmax is defined as the time (observed time point) of Cmax.

Participants in the PK Substudy Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

hours

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

PK Parameter: CL/F of Selgantolimod

CL/F is defined as the apparent oral clearance following administration of the drug.

Participants in the PK Substudy Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

mL/hr

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Secondary

PK Parameter: t1/2 of Selgantolimod

t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Participants in the PK Substudy Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

hours

Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Day 1 and Week 23

ID	Title	Description
OG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.
OG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Selgantolimod 3 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	26	1	26	21	26
EG001	Selgantolimod 1.5 mg + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received selgantolimod 1.5 mg (1 x 1.5 mg tablet) and placebo (1 tablet) orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, selgantolimod was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	28	0	28	15	28
EG002	Placebo + TAF	Participants with HBeAg-positive CHB or HBeAg-negative CHB currently not on OAV treatment, received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses along with the TAF 25 mg orally once daily for 24 weeks. After the 24th dose, placebo was discontinued, and participants continued to receive TAF until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	13	0	13	10	13

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Dry eye	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Eye pruritus	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Ocular hyperaemia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0010 affected28 at risk EG0020 affected13 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected28 at risk EG0020 affected13 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected26 at risk EG0013 affected28 at risk EG0020 affected13 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected26 at risk EG0011 affected28 at risk EG0022 affected13 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected28 at risk EG0020 affected13 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected28 at risk EG0020 affected13 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0008 affected26 at risk EG0016 affected28 at risk EG0020 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0006 affected26 at risk EG0013 affected28 at risk EG0020 affected13 at risk
Chest discomfort	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected28 at risk EG0020 affected13 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Chills	General disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected26 at risk EG0010 affected28 at risk EG0020 affected13 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0005 affected26 at risk EG0013 affected28 at risk EG0020 affected13 at risk
Feeling cold	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0010 affected28 at risk EG0020 affected13 at risk
Malaise	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Eye infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0013 affected28 at risk EG0021 affected13 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected28 at risk EG0023 affected13 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0013 affected28 at risk EG0020 affected13 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Low density lipoprotein increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0010 affected28 at risk EG0020 affected13 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected28 at risk EG0021 affected13 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0005 affected26 at risk EG0011 affected28 at risk EG0020 affected13 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected26 at risk EG0015 affected28 at risk EG0022 affected13 at risk
Memory impairment	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0011 affected28 at risk EG0020 affected13 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0012 affected28 at risk EG0020 affected13 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0011 affected28 at risk EG0021 affected13 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected26 at risk EG0010 affected28 at risk EG0020 affected13 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 affected26 at risk EG0010 affected28 at risk EG0020 affected13 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 affected26 at risk EG0010 affected28 at risk EG0021 affected13 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