Phase 2 Hepatitis B Trial, Completed NCT04891770 Sponsor: Gilead Sciences Condition: Hepatitis B
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT04891770) enrolled 103 people with chronic hepatitis B infection across three groups. Cohort 1 (42 people) received four treatments together: TAF, VIR-2218, selgantolimod (SLGN), and nivolumab. Cohort 2 Group A (40 people) received VIR-2218, SLGN, and nivolumab. Cohort 2 Group B (21 people) received SLGN and nivolumab only. The trial's main goal was to measure how many participants achieved what researchers called a "functional cure" — defined as losing a specific hepatitis B protein from the blood (called HBsAg) while also having the hepatitis B virus fall below a detectable level, both measured at 24 weeks after treatment ended. The reported data shows that very few participants met the primary "functional cure" definition. Approximately 2.4% of Cohort 1, 2.5% of Cohort 2 Group A, and 0% of Cohort 2 Group B reached this outcome. For the secondary outcomes, the reported data shows that none of the participants across all three groups achieved HBsAg loss (with or without producing protective antibodies against HBsAg) at any point during the study. Among participants who were positive for another hepatitis B marker (HBeAg) at the start, small percentages lost that marker during the study — reported as 5.6% in Cohort 1 and 0% in both Cohort 2 groups — while 11.1% of Cohort 1 and 6.3% of Cohort 2 Group A went on to develop the corresponding protective antibody. The reported data also shows that the percentage of participants who remained off their usual antiviral tablets (called NUC treatments) during follow-up was 16.7% in Cohort 1, 55.6% in Cohort 2 Group A, and 75.0% in Cohort 2 Group B. Separately, a rebound in the virus during treatment (called "virologic breakthrough") was reported in 7.1% of Cohort 1, 35.0% of Cohort 2 Group A, and 20.0% of Cohort 2 Group B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Hepatitis B Trial, Completed

NCT04891770
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to give your agreement to take part in the study
  • You have had a long-term hepatitis B virus (HBV) infection for at least 6 months
  • You are willing to follow the study's rules about using contraception (birth control)

Who may not be able to join:

  • You have significant scarring or severe damage to your liver (such as advanced fibrosis or cirrhosis)
  • You currently have or have previously had liver cancer
  • You have a condition where your immune system attacks your own body (an autoimmune disease)
  • You have another long-term liver disease in addition to hepatitis B
  • You are a woman who is currently breastfeeding, pregnant, or planning to become pregnant during the study

Important: This list may not include all of the study's eligibility requirements, so always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Gilead Study Director, Gilead Sciences

Australian sites

Liverpool Hospital, Liverpool, New South Wales
Royal Melbourne Hospital, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
14 August 2021
Est. completion
23 January 2024

Where this trial is recruiting

🇦🇺 Australia 🇩🇰 Denmark Hong Kong 🇳🇿 New Zealand 🇸🇬 Singapore 🇰🇷 South Korea 🇹🇭 Thailand 🇬🇧 United Kingdom

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieved Functional Cure

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov