Trial intelligence / Profile preview

VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

NCT06092333Phase 2

Key facts

Status
Active, not recruiting
Start
Jan 2025
Primary completion
Feb 2028
Countries
1
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases
Conditions
Chronic Hepatitis B (CHB)
01

Overview

Phase 2, open-label, single-arm trial of elebsiran in Chronic Hepatitis B (CHB), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases. Primary endpoint: Decline in log quantitative HBsAg level at 60 weeks. Started Jan 2025; status: active, not recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Single arm, open label

    All participants receive the sequential regimen of VIR-2218 and peginterferon alfa-2a.

03

Who it enrols

Adults aged 18-65 with untreated, HBeAg-negative chronic hepatitis B, low viral load, and no cirrhosis.

04

Endpoints

Primary

  • Decline in log quantitative HBsAg level

Secondary

  • Changes in innate and adaptive host immune responses to HBV

  • HBV DNA <10 IU/ml

  • Functional cure

  • Safety and tolerability

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