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NCT04749368
PHASE2

Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

Sponsor: Brii Biosciences Limited

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2021-04-12

Completion Date

2023-07-04

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

BRII-835 (VIR-2218)

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

BIOLOGICAL

BRII-179 (VBI-2601) with IFN-α

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

BIOLOGICAL

BRII-179 (VBI-2601)

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

Locations (28)

Investigative Site 61002

Kingswood, New South Wales, Australia

Investigative Site 61001

Westmead, New South Wales, Australia

Investigative Site 61004

Herston, Queensland, Australia

Investigative Site 88602

Changhua, Taiwan, China

Investigative Site 85201

Hong Kong, China

Investigative Site 85202

Hong Kong, China

Investigative Site 85203

Hong Kong, China

Investigative Site 88601

Kaohsiung, Taiwan, China

Investigative Site 88604

Kaohsiung, Taiwan, China

Investigative Site 85204

NEW Territories, Hong Kong, China

Investigative Site 88603

Taichung, Taiwan, China

Investigative Site 88605

Taipei CITY, China

Investigative Site 64002

Dunedin Central, Dunedin, New Zealand

Investigative Site 64001

Auckland, New Zealand

Investigative Site 65001

Singapore, Singapore

Investigative Site 65002

Singapore, Singapore

Investigative Site 82004

Busan, South Korea

Investigative Site 82003

Seongnam-si, Gyeonggi-do, South Korea

Investigative Site 82001

Seoul, South Korea

Investigative Site 82005

Seoul, South Korea

Investigative Site 82002

Seoul, South Korea

Investigative Site 66001

Bangkok, Thailand

Investigative Site 66003

Chiang Mai, Thailand

Investigative Site 66002

Khon Kaen, Thailand

Investigative Site 66005

Nonthaburi, Thailand

Investigative Site 66006

Nonthaburi, Thailand

Investigative Site 66004

Pathum Thani, Thailand

Investigative Site 66007

Songkhla, Thailand