Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
NCT ID: NCT04891770
Last Updated: 2025-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2021-08-14
2024-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab
Nucleos(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.
Tenofovir Alafenamide
Administered as film-coated oral tablets
VIR-2218
Administered as a sub-cutaneous (SC) injection
Nivolumab
Administered intravenously
Selgantolimod
Administered as film-coated oral tablets
Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab
Viremic 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.
Tenofovir Alafenamide
Administered as film-coated oral tablets
VIR-2218
Administered as a sub-cutaneous (SC) injection
Nivolumab
Administered intravenously
Selgantolimod
Administered as film-coated oral tablets
Cohort 2 Group B: SLGN + Nivolumab
Viremic 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.
Tenofovir Alafenamide
Administered as film-coated oral tablets
Nivolumab
Administered intravenously
Selgantolimod
Administered as film-coated oral tablets
Interventions
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Tenofovir Alafenamide
Administered as film-coated oral tablets
VIR-2218
Administered as a sub-cutaneous (SC) injection
Nivolumab
Administered intravenously
Selgantolimod
Administered as film-coated oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HBV infection for at least 6 months
* Willing to follow protocol-specified contraception requirement
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus N, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Odense University Hospital
Odense, , 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, , New Zealand
National University Hospital
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Saint Mary Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Thai Red Cross AIDS Research Centre (HIV-NAT)
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
Muang, , Thailand
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
Pan 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.
Gane 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2021-000672-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-465-4439
Identifier Type: -
Identifier Source: org_study_id
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