Clinical trial

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Name

BRII-835-002

Description

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.

Trial arms

Trial start

2023-08-22

Estimated PCD

2025-08-01

Trial end

2026-02-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

PEG-IFNα

PEG-IFNα will be given via subcutaneous injection

Arms:

Cohort 1, Cohort 2, Cohort 3, Cohort 4

Other names:

pegylated interferon alfa

BRII-835

BRII-835 will be given via subcutaneous injection

Arms:

Cohort 2, Cohort 3, Cohort 4

Size

Primary endpoint

Proportion of participants with HBsAg loss at end of treatment

Up to Week 48

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

Up to Week 72

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

Up to Week 72

Proportion of participants with serious adverse events (SAEs)

Up to Week 72

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

Updated at

2024-03-21

1 organization

2 products

1 indication

Product

Indication

Product

Organization