NCT04891770

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide	Administered as film-coated oral tablets
DRUG	VIR-2218	Administered as a sub-cutaneous (SC) injection
DRUG	Nivolumab	Administered intravenously
DRUG	Selgantolimod	Administered as film-coated oral tablets

Timeline

• Start date: 2021-08-14
• Primary completion: 2024-01-23
• Completion: 2024-07-19
• First posted: 2021-05-18
• Last updated: 2025-07-24
• Results posted: 2025-07-24

Locations

26 sites across 8 countries: Australia, Denmark, Hong Kong, New Zealand, Singapore, South Korea, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study