Phase 2
N=103
Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT04891770 ↗Enrolled (actual)
103
Serious AEs
9.8%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants Who Achieved Functional Cure — 2.4; 2.5; 0.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tenofovir Alafenamide (Drug); VIR-2218 (Drug); Nivolumab (Drug); Selgantolimod (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Functional Cure |
2.4; 2.5; 0.0 | — |
| SECONDARY Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
5.6; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Remain Off NUC Treatment During Follow-Up |
16.7; 55.6; 75.0 | — |
| SECONDARY Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During Study Treatments |
7.1; 35.0; 20.0 | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide informed consent
- Chronic HBV infection for at least 6 months
- Willing to follow protocol-specified contraception requirement
Key Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04891770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.