Chronic Hepatitis BPhase 2NCT03491553

Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B

A Phase 2 study testing Selgantolimod and Hepatitis B virus (HBV) OAV Therapy in people with Chronic Hepatitis B, run by Gilead Sciences at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: Selgantolimod and Hepatitis B virus (HBV) OAV Therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 2 sitesin 2 countries
Study dates: 6 Apr 2018to 10 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Adult males and non-pregnant, non-lactating females
Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening
Screening Electrocardiogram (ECG) without clinically significant abnormalities

Who cannot join

Extensive bridging fibrosis or cirrhosis
Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:
Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)
International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen
Albumin < 3.5 g/dL
Direct bilirubin > 1.5x ULN

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Platelet Count < 100,000/uL
Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201

Other trials in United States

New Zealand1 site

Auckland Clinical Studies Limited
Auckland, 1010

Other trials in New Zealand

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B

Conditions: Chronic Hepatitis B
Being tested: Selgantolimod, Placebo, Hepatitis B virus (HBV) OAV Therapy
Medical subject headings: Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelgantolimodDrug
Also called GS-9688
Tablet(s) administered orally once weekly
PlaceboDrug
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Hepatitis B virus (HBV) OAV TherapyDrug
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®)

Study groups in NCT03491553
Study group	Role	What they receive
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. Receives: Drug: Selgantolimod; Drug: Hepatitis B virus (HBV) OAV Therapy
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. Receives: Drug: Selgantolimod; Drug: Hepatitis B virus (HBV) OAV Therapy
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. Receives: Drug: Selgantolimod; Drug: Placebo; Drug: Hepatitis B virus (HBV) OAV Therapy
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. Receives: Drug: Selgantolimod; Drug: Placebo; Drug: Hepatitis B virus (HBV) OAV Therapy
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. Receives: Drug: Placebo; Drug: Hepatitis B virus (HBV) OAV Therapy
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. Receives: Drug: Placebo; Drug: Hepatitis B virus (HBV) OAV Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (17)

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Measured: Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Measured: Week 8
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Measured: Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Measured: Week 48
Change From Baseline in Serum qHBsAg at Week 4
Measured: Baseline, Week 4
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
Measured: Baseline, Week 8
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
Measured: Baseline, Week 12
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 201810 Aug 2020

First posted9 Apr 2018
Study start6 Apr 2018
Primary completion22 Mar 2019
Study completion10 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03491553
Sponsor's protocol ID: GS-US-389-2024
Other IDs: ACTRN12618000143224p
Status last verified: Jul 2021
First submitted: 2 Apr 2018
Last updated: 19 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
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.
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.
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.
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.
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.
PubMed 38133554

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT03491553
Acronym / sponsor ID: GS-US-389-2024
Conditions: Chronic Hepatitis B
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 6 Apr 2018 (actual)
Primary completion: 22 Mar 2019 (actual)
Study completion: 10 Aug 2020 (actual)
First posted: 9 Apr 2018 (actual)
Results: Posted 1 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Selgantolimod 3 mg: HBeAg-positive CHB Participants	Experimental	Drug: Selgantolimod, Drug: Hepatitis B virus (HBV) OAV TherapyParticipants 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	Drug: Selgantolimod, Drug: Hepatitis B virus (HBV) OAV TherapyParticipants 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	Drug: Selgantolimod, Drug: Placebo, Drug: Hepatitis B virus (HBV) OAV TherapyParticipants 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.
Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Experimental	Drug: Selgantolimod, Drug: Placebo, Drug: Hepatitis B virus (HBV) OAV TherapyParticipants 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	Drug: Placebo, Drug: Hepatitis B virus (HBV) OAV TherapyParticipants 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	Drug: Placebo, Drug: Hepatitis B virus (HBV) OAV TherapyParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Adult males and non-pregnant, non-lactating females
Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelgantolimodAlso: GS-9688Tablet(s) administered orally once weekly	Drug	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Selgantolimod 3 mg: HBeAg-negative CHB Participants, Selgantolimod 3 mg: HBeAg-positive CHB Participants
PlaceboPlacebo to match (PTM) selgantolimod tablet(s) administered orally once weekly	Drug	Placebo: HBeAg-negative CHB Participants, Placebo: HBeAg-positive CHB Participants, Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Selgantolimod 1.5 mg: HBeAg-positive CHB Participants
Hepatitis B virus (HBV) OAV TherapyCommercially 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®)	Drug	Placebo: HBeAg-negative CHB Participants, Placebo: HBeAg-positive CHB Participants, Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Selgantolimod 3 mg: HBeAg-negative CHB Participants, Selgantolimod 3 mg: HBeAg-positive CHB Participants

Primary outcome

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

17 secondary outcomes

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Time frame: Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Time frame: Week 8
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Time frame: Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Time frame: Week 48
Change From Baseline in Serum qHBsAg at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
Time frame: Baseline, Week 48
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
Time frame: Week 12
Percentage of Participants With HBsAg Loss at Week 24
Time frame: Week 24
Percentage of Participants With HBsAg Loss at Week 48
Time frame: Week 48
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
Time frame: Week 12
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Time frame: Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Time frame: Week 48
Percentage of Participants With Virologic Breakthrough
Time frame: Baseline up to Week 48
Percentage of Participants With Drug Resistance Mutations
Time frame: Baseline up to Week 48

Results and safety

Results posted to the registry on 1 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selgantolimod 3 mg: HBeAg-positive CHB Participants	9	8
Selgantolimod 3 mg: HBeAg-negative CHB Participants	10	9
Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	10	10
Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	10	9
Placebo: HBeAg-positive CHB Participants	5	5
Placebo: HBeAg-negative CHB Participants	4	4

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

Time frame: Week 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n = 9	Selgantolimod 3 mg: HBeAg-negative CHB Participants n = 10	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n = 10	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n = 10	Placebo: HBeAg-positive CHB Participants n = 5	Placebo: HBeAg-negative CHB Participants n = 4
Value	0 (0.0 to 33.6)	0 (0.0 to 30.8)	0 (0.0 to 30.8)	10.0 (0.3 to 44.5)	0 (0.0 to 52.2)	0 (0.0 to 60.2)

Selgantolimod 3 mg: HBeAg-positive CHB Participants vs Placebo: HBeAg-positive CHB Participants: Percentage Difference: 0.0
Selgantolimod 3 mg: HBeAg-negative CHB Participants vs Placebo: HBeAg-negative CHB Participants: Percentage Difference: 0.0
Selgantolimod 1.5 mg: HBeAg-positive CHB Participants vs Placebo: HBeAg-positive CHB Participants: Percentage Difference: 0.0

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

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selgantolimod 3 mg: HBeAg-positive CHB Participants	1 of 9 (11.1%)	9 of 9 (100%)	0 of 9
Selgantolimod 3 mg: HBeAg-negative CHB Participants	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	1 of 10 (10%)	8 of 10 (80%)	0 of 10
Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	2 of 10 (20%)	10 of 10 (100%)	0 of 10
Placebo: HBeAg-positive CHB Participants	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Placebo: HBeAg-negative CHB Participants	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationBrooks 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.
Results publicationGane 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.
Results publicationChen 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.
Results publicationChen 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.
Results publicationGane 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.
Derived from this study: PubMed 38133554Gane 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selgantolimod and Hepatitis B virus (HBV) OAV Therapy in people with Chronic Hepatitis B, run by Gilead Sciences at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03491553, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.