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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12618000143224p | Registry Identifier | ANZCTR |
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The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selgantolimod 3 mg: HBeAg-positive CHB Participants | Experimental | Participants with Hepatitis B e Antigen (HBeAg)-positive CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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. |
|
| Selgantolimod 3 mg: HBeAg-negative CHB Participants | Experimental | Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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. |
|
| Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Experimental | Participants with HBeAg-positive CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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 |
|---|---|---|---|---|
| Selgantolimod | Drug | Tablet(s) administered orally once weekly |
|
| 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 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 | Week 4 | |
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 | Week 8 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Extensive bridging fibrosis or cirrhosis
Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:
Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging
Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators or biologics within 3 months of screening
Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Institute of Human Virology | Baltimore | Maryland | 21201 | United States | ||
| Auckland Clinical Studies Limited |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Brooks AE, Verdon D, Eom J, Ng J, Steemson H, Lau AH, et al. Peripheral Immune Responses to Toll-Like Receptor 8 Agonist Selgantolimod (GS-9688) in Patients with Chronic Hepatitis B [Poster]. AASLD: The Liver Meeting® 2019; 2019 08-12 November; Boston, MA. | ||
| Result | Gane E, Zhao Y, Tan SK, Lau AH, Gaggar A, Subramanian M, et al. Efficacy and Safety of Oral TLR8 Agonist Selgantolimod in Virally Suppressed Adult Patients With Chronic Hepatitis B: a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study [Poster 697]. AASLD: The Liver Meeting® 2019; 2019 08-12 November; Boston, MA. | ||
| Result | Chen DY, C. M, Tan SK, Yang JC, Gane EJ, Janssen HLA, et al. Characterization of Cytokine Response to Toll-Like Receptor 8 Agonist Selgantolimod in Viremic and Virally Suppressed Chronic Hepatitis B Patients [Poster 0721]. American Association for the Study of Liver Diseases (AASLD): The Liver Meeting Digital Experience; 2020 13-16 November. | ||
| Result | 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 FR1350]. The Digital International Liver Congress (ILC); 2020 27-29 August. | ||
| Result | Gane E, Dubar PR, Brooks AE, Zhao Y, Tan SK, Lau AH, et al. Efficacy and Safety of 24 Weeks Treatment with Oral TLR8 Agonist Selgantolimod (GS-9688, SLGN) in Virally Suppressed Adult Patients with Chronic Hepatitis B: A Phase 2 Study [Presentation]. The Digital International Liver Congress (ILC); 2020 27-29 August. |
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59 participants were screened.
Participants were enrolled at study sites in New Zealand and the United States. The first participant was screened on 6 April 2018. The last study visit occurred on 10 August 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Selgantolimod 3 mg: HBeAg-positive CHB Participants | Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) remained on their current oral antiviral (OAV) and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants could continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks. |
| FG001 | Selgantolimod 3 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| FG002 | Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| FG003 | Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| FG004 | Placebo: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| FG005 | Placebo: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study (Up to Week 48) |
|
| ||||||||||||||||||
| TFFU (Week 49 up to Additional 48 Weeks) |
|
The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Selgantolimod 3 mg: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 95% Confidence Interval | percentage of participants | Week 24 |
|
Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months
Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug.
All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selgantolimod 3 mg: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| 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 | Feb 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Week 24 Analysis and Final Analysis | Jan 18, 2019 | Feb 17, 2020 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: TFFU (Treatment-Free Follow-Up) Analysis | Sep 11, 2020 | Jul 20, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000712275 | selgantolimod |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Experimental | Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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. |
|
| Placebo: HBeAg-positive CHB Participants | Experimental | Participants with HBeAg-positive CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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. |
|
| Placebo: HBeAg-negative CHB Participants | Experimental | Participants with HBeAg-negative CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy 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. |
|
|
| Placebo | Drug | Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly |
|
| Hepatitis B virus (HBV) OAV Therapy | Drug | Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®) |
|
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 | Week 12 |
| Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 | Week 48 |
| Change From Baseline in Serum qHBsAg at Week 4 | Baseline, Week 4 |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | Baseline, Week 8 |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | Baseline, Week 12 |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | Baseline, Week 24 |
| Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | Baseline, Week 48 |
| 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. | Week 12 |
| 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. | Week 24 |
| 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. | Week 48 |
| 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 HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. | Week 12 |
| 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 test changing from negative or missing at baseline to positive at a postbaseline visit. | Week 24 |
| 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 hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit. | Week 48 |
| Percentage of Participants With Virologic Breakthrough | Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL. | Baseline up to Week 48 |
| Percentage of Participants With Drug Resistance Mutations | The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL. | Baseline up to Week 48 |
| Auckland |
| 1010 |
| New Zealand |
| 38133554 | Derived | Gane EJ, Dunbar PR, Brooks AE, Zhang F, Chen D, Wallin JJ, van Buuren N, Arora P, Fletcher SP, Tan SK, Yang JC, Gaggar A, Kottilil S, Tang L. Safety and efficacy of the oral TLR8 agonist selgantolimod in individuals with chronic hepatitis B under viral suppression. J Hepatol. 2023 Mar;78(3):513-523. doi: 10.1016/j.jhep.2022.09.027. Epub 2022 Oct 29. |
| Withdrew Consent |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Selgantolimod 3 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| BG002 | Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| BG003 | Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| BG004 | Placebo: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| BG005 | Placebo: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Hepatitis B Surface Antigen (HBsAg) | Mean | Standard Deviation | log10 IU/mL |
|
Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
| OG002 | Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. |
| OG003 | Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. |
| OG004 | Placebo: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. |
| OG005 | Placebo: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. |
|
|
|
| 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 | 95% Confidence Interval | percentage of participants | Week 4 |
|
|
|
|
| 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 | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
|
|
| 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 | 95% Confidence Interval | percentage of participants | Week 12 |
|
|
|
|
| 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 | 95% Confidence Interval | percentage of participants | Week 48 |
|
|
|
|
| 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 |
|
|
|
| Secondary | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 48 |
|
|
|
| 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 were analyzed. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| 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 were analyzed. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| 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 were analyzed. | Posted | Number | percentage of participants | Week 48 |
|
|
|
| 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 HBeAb test changing from negative or 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 12 |
|
|
|
| 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 test changing from negative or 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 |
|
|
|
| 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 hepatitis B e antibody (HBeAb) test changing from negative or 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 48 |
|
|
|
| Secondary | Percentage of Participants With Virologic Breakthrough | Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL. | There were no participants analyzed for the outcome measure since none of the participants met the criteria. | Posted | Baseline up to Week 48 |
|
|
| Secondary | Percentage of Participants With Drug Resistance Mutations | The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL. | There were no participants analyzed for the outcome measure since none of the participants met the criteria. | Posted | Baseline up to Week 48 |
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 9 |
| 9 |
| EG001 | Selgantolimod 3 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG002 | Selgantolimod 1.5 mg: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 0 | 10 | 1 | 10 | 8 | 10 |
| EG003 | Selgantolimod 1.5 mg: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 0 | 10 | 2 | 10 | 10 | 10 |
| EG004 | Placebo: HBeAg-positive CHB Participants | Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | Placebo: HBeAg-negative CHB Participants | Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
| Iridocyclitis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Perineal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
|
| Borderline glaucoma | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Optic disc disorder | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pinguecula | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Exercise tolerance decreased | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Perineal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Citrate toxicity | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Urine output increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| 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 |
| D045424 |
| Complex Mixtures |
| 0.0 |
| 2-Sided |
| 95 |
| Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| 0.0 |
| 2-Sided |
| 95 |
| Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| 0.0 |
| 2-Sided |
| 95 |
| Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| 0.0 |
| 2-Sided |
| 95 |
| Other |
| Percentage Difference | 0.0 | 2-Sided | 95 | Other |
| Percentage Difference | 10.0 | 2-Sided | 95 | -47.2 | 47.1 | The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests. | Other |
|
|
|