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

NCT04891770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-07-24

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Vir Biotechnology, Inc.

    collaborator INDUSTRY

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-14
Primary Completion
2024-01-23
Completion
2024-07-19
FDA Drug
Yes

Countries

  • Australia
  • Denmark
  • Hong Kong
  • New Zealand
  • Singapore
  • South Korea
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891770 on ClinicalTrials.gov