Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
2 other identifiers
interventional
103
8 countries
26
Brief Summary
The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) \< lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedStudy Start
First participant enrolled
August 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2024
CompletedResults Posted
Study results publicly available
July 24, 2025
CompletedJuly 24, 2025
July 1, 2025
2.4 years
May 14, 2021
July 7, 2025
July 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Functional Cure
Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off.
At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48)
Secondary Outcomes (4)
Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion
Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline
Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)
Percentage of Participants Who Remain Off NUC Treatment During Follow-Up
Cohort 1 and Cohort 2A: From Week 36 up to Week 84 and for Cohort 2B: From Week 24 up to Week 72
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments
Up to 36 Weeks
Study Arms (3)
Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab
EXPERIMENTALNucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) will receive tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants will receive selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who are on TAF treatment will continue TAF treatment over the duration of study follow-up. Participants will be followed up for 48 weeks post treatment.
Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab
EXPERIMENTALViremic participants with CHB will receive VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who meet the criteria to initiate NUC treatment will receive TAF 25, mg orally, QD during the study. Participants will be followed up for 48 weeks post treatment.
Cohort 2 Group B: SLGN + Nivolumab
EXPERIMENTALViremic participants with CHB will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. . Viremic participants who meet the criteria to initiate NUC treatment will receive TAF 25 mg orally QD during the study. Participants will be followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision.
Interventions
Administered as film-coated oral tablets
Administered as a sub-cutaneous (SC) injection
Administered intravenously
Administered as film-coated oral tablets
Eligibility Criteria
You may qualify if:
- Willing and able to provide informed consent
- Chronic HBV infection for at least 6 months
- Willing to follow protocol-specified contraception requirement
You may not qualify if:
- Have extensive fibrosis or cirrhosis in the liver
- Have or had liver cancer (hepatocellular carcinoma)
- Have an autoimmune disease
- Have chronic liver disease other than HBV
- Females who are breastfeeding, pregnant, or who wish to become pregnant during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Vir Biotechnology, Inc.collaborator
Study Sites (26)
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Aalborg University Hospital
Aalborg, DK9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense, DK5000, Denmark
Princess Margaret Hospital (Hong Kong)
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Auckland City Hospital
Grafton, 1010, New Zealand
National University Hospital
Singapore, 119228, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Singapore General Hospital
Singapore, Singapore
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul Saint Mary Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Yonsei University Severance Hospital
Seoul, 120-752, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Thai Red Cross AIDS Research Centre (HIV-NAT)
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
Muang, 50200, Thailand
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Related Publications (3)
Wong GL, Lim SG, Agarwal K, Avihingsanon A, Lim Y, et al. Results From a Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Novel Combination Therapies Containing VIR-2218, Selgantolimod, and Nivolumab for the Treatment of Chronic Hepatitis B. Poster #1380; Presented at The Liver Meeting, American Association for the Study of Liver Diseases; 2024 November 15-19; San Diego, CA.
BACKGROUNDPan D, Kolhatkar N, Sowah L, Arizpe A, Cloutier D, et al. Immunologic Biomarker Dynamics in Chronic Hepatitis B: Insights From a Phase 2a Open-Label Study on Combination Therapies With Small Interfering RNA, Selgantolimod, and Nivolumab. Poster #1134; Presented at The Liver Meeting, American Association for the Study of Liver Diseases; 2024 November 15-19; San Diego, CA.
BACKGROUNDGane EJ, Tanwandee T, Yi B, Chew T, Botros I, et al. Immune-Related Adverse Events With Low-Dose Nivolumab in Patients With Chronic Hepatitis B: Experience From 3 Clinical Studies. Poster #1332; Presented at The Liver Meeting, American Association for the Study of Liver Diseases; 2024 November 15-19; San Diego, CA.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2021
First Posted
May 18, 2021
Study Start
August 14, 2021
Primary Completion
January 23, 2024
Study Completion
July 19, 2024
Last Updated
July 24, 2025
Results First Posted
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share