Clinical trial

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Name

BRII-179-835-001

Description

This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

Trial arms

Trial start

2021-04-12

Estimated PCD

2023-07-04

Trial end

2023-07-04

Status

Completed

Phase

Early phase I

Treatment

BRII-835 (VIR-2218)

BRII-835 (VIR-2218) will be given by subcutaneous injection

Arms:

Cohort A, Cohort B, Cohort C

BRII-179 (VBI-2601) with IFN-α

BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection

Arms:

Cohort B

BRII-179 (VBI-2601)

BRII-179 (VBI-2601) will be administered by intramuscular injection

Arms:

Cohort C

Size

Primary endpoint

Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal

up to Week 96

Number of participants with Adverse Events (AE)

up to Week 96

Number of participants with Serious Adverse Events (SAE)

up to Week 96

Number of participants with abnormalities in clinical laboratory tests

up to Week 96

Eligibility criteria

Inclusion Criteria: * Male or female aged 18 - 60 * Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2 * Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * Significant fibrosis or cirrhosis * History or evidence of drug or alcohol abuse * History of intolerance to SC or IM injection * History of chronic liver disease from any cause other than chronic HBV infection * History of hepatic decompensation

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 91, 'type': 'ACTUAL'}}

Updated at

2023-10-11

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product