Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Phase 2Active Not RecruitingNCT05970289

Brii Biosciences Limited86 enrolled

Overview

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B Virus Infection

Interventions

PEG-IFNαBIOLOGICAL

PEG-IFNα will be given via subcutaneous injection

BRII-835DRUG

BRII-835 will be given via subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 18-60. * Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy for at least 6 months. Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * Significant liver fibrosis or cirrhosis. * History or evidence of drug or alcohol abuse. * History of intolerance to SC injection. * History of chronic liver disease from any cause other than chronic HBV infection. * History of hepatic decompensation. * Contraindications to the use of Peg-IFNα.

Locations (29)

Outcomes

Primary Outcomes

Proportion of participants with HBsAg loss at end of treatment

Time frame: Up to Week 48

Proportion of participants with HBsAg loss at 24 weeks post-end of treatment

Time frame: Up to Week 72

Proportion of participants with treatment-emergent adverse events (TEAEs)

Time frame: Up to Week 72

Proportion of participants with serious adverse events (SAEs)

Time frame: Up to Week 72

Data from ClinicalTrials.gov

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