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

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).

Timeline

Start

2021-08-14

Primary completion

2024-01-23

Completion

2024-07-19

Publications

• Background 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.
• Background 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.
• Background 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.

Drugs

Indications