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Chronic Hepatitis BPhase 2NCT04891770

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

A Phase 2 study testing Tenofovir Alafenamide, VIR-2218 and Nivolumab in people with Chronic Hepatitis B, run by Gilead Sciences at 26 sites in 8 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 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… 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?
Tenofovir Alafenamide, VIR-2218 and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
26 sitesin 8 countries
Study dates
14 Aug 2021to 19 Jul 2024
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

  • Willing and able to provide informed consent
  • Chronic HBV infection for at least 6 months
  • Willing to follow protocol-specified contraception requirement

Who cannot join

  • 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

26 sites in 8 countries.

26 sites in 8 countries

South Korea7 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul Saint Mary Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Yonsei University Severance Hospital

    Seoul, 120-752

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, DK9000

  • Aarhus University Hospital

    Aarhus N, 8200

  • Hvidovre Hospital

    Hvidovre, 2650

  • Odense University Hospital

    Odense, DK5000

Other trials in Denmark

Hong Kong4 sites

  • Princess Margaret Hospital (Hong Kong)

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po

Other trials in Hong Kong

Thailand4 sites

  • Thai Red Cross AIDS Research Centre (HIV-NAT)

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital

    Muang, 50200

Other trials in Thailand

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Changi General Hospital

    Singapore, 529889

  • Singapore General Hospital

    Singapore

Other trials in Singapore

Australia2 sites

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

New Zealand1 site

  • Auckland City Hospital

    Grafton, 1010

Other trials in New Zealand

United Kingdom1 site

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: 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)

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).

Being tested
Tenofovir Alafenamide, VIR-2218, Nivolumab, Selgantolimod
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.

  • Tenofovir AlafenamideDrug

    Also called TAF, Vemlidy®, GS-7340

    Administered as film-coated oral tablets

  • VIR-2218Drug

    Administered as a sub-cutaneous (SC) injection

  • NivolumabDrug

    Also called Opdivo®

    Administered intravenously

  • SelgantolimodDrug

    Also called SLGN, GS-9688

    Administered as film-coated oral tablets

Study groups in NCT04891770
Study groupRoleWhat they receive
Cohort 1: TAF + VIR-2218 + SLGN + NivolumabExperimentalNucleos(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.
Receives: Drug: Tenofovir Alafenamide; Drug: VIR-2218; Drug: Nivolumab; Drug: Selgantolimod
Cohort 2 Group A: VIR-2218 + SLGN + NivolumabExperimentalViremic 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.
Receives: Drug: Tenofovir Alafenamide; Drug: VIR-2218; Drug: Nivolumab; Drug: Selgantolimod
Cohort 2 Group B: SLGN + NivolumabExperimentalViremic 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.
Receives: Drug: Tenofovir Alafenamide; Drug: Nivolumab; Drug: Selgantolimod

What is being measured

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

  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.

    Measured: At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48)

Secondary outcomes (4)

  1. Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion

    HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. Percentages were rounded-off.

    Measured: Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)

  2. 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

    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit. Percentages were rounded-off.

    Measured: Up to Follow-up Week 48 (Cohort 1 and Cohort 2A: At Week 84; Cohort 2B: At Week 72)

  3. Percentage of Participants Who Remain Off NUC Treatment During Follow-Up

    NUC treatments included for analysis: adefovir dipivoxil, entecavir, telbivudine, tenofovir, tenofovir alafenamide, tenofovir alafenamide fumarate, tenofovir disoproxil fumarate, and lamivudine. Percentages were rounded-off.

    Measured: Cohort 1 and Cohort 2A: From Week 36 up to Week 84 and for Cohort 2B: From Week 24 up to Week 72

  4. Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments

    Virologic breakthrough was defined as confirmed HBV DNA ≥ LLOQ after 2 consecutive HBV DNA < LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA ≥ 1 log10 IU/mL increase from nadir during study treatments. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. Percentages were rounded-off.

    Measured: Up to 36 Weeks

Timeline

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

  1. First posted18 May 2021
  2. Study start14 Aug 2021
  3. Primary completion23 Jan 2024
  4. Study completion19 Jul 2024

Resources

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
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04891770
Sponsor's protocol ID
GS-US-465-4439
Other IDs
2021-000672-11
Status last verified
Jul 2025
First submitted
14 May 2021
Last updated
24 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tenofovir Alafenamide, VIR-2218 and Nivolumab in people with Chronic Hepatitis B, run by Gilead Sciences at 26 sites in 8 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 3 inclusion and 6 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea, Denmark, Hong Kong, Thailand, Singapore and 3 more countries. 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 24 Jul 2025). 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 Who Achieved Functional Cure (time frame: At Follow-up Week 24 (Cohort 1 and Cohort 2A: At Week 60; Cohort 2B: At Week 48)). 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 NCT04891770, which also lists 3 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 24 Jul 2025.

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