LAST UPDATED
July 24, 2025
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
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)
PROTOCOL 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).
View moreParticipation requirements
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Chronic Hepatitis B
Gender
N/A
Date
August 2021 - January 2024
Study Type
Interventional
Study Phase
Phase 2
Product
Tenofovir Alafenamide, VIR-2218, Nivolumab, Selgantolimod
Eligibility information
Inclusion criteria
- Willing and able to provide informed consent
- Chronic HBV infection for at least 6 months
- Willing to follow protocol-specified contraception requirement
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.
Locations
Locations (26)
Thai Red Cross AIDS Research Centre (HIV-NAT)
Bangkok, Thailand, 10330
Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital
Muang, Thailand, 50200
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
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