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RECRUITING
NCT06650852
PHASE2

A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Sponsor: Brii Biosciences Limited

View on ClinicalTrials.gov

Summary

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Official title: A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-10-31

Completion Date

2027-07

Last Updated

2025-05-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

BRII-179

BRII-179 will be given via intramuscular injection

DRUG

BRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICAL

PEG-IFNα

PEG-IFNα will be given via subcutaneous injection

DRUG

Placebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

DRUG

Placebo of BRII-835

Placebo of BRII-835 will be given via subcutaneous injection

Locations (14)

Investigative Site 86001

Beijing, Beijing Municipality, China

Investigative Site 86003

Beijing, Beijing Municipality, China

Investigative Site 86004

Beijing, Beijing Municipality, China

Investigative Site 86005

Beijing, Beijing Municipality, China

Investigative Site 86016

Beijing, Beijing Municipality, China

Investigative Site 86002

Guangzhou, Guangdong, China

Investigative Site 86013

Guangzhou, Guangdong, China

Investigative Site 86015

Shenzhen, Guangdong, China

Investigative Site 86006

Shanghai, Shanghai Municipality, China

Investigative Site 86007

Shanghai, Shanghai Municipality, China

Investigative Site 86010

Chengdu, Sichuan, China

Investigative Site 86011

Chengdu, Sichuan, China

Investigative Site 86012

Chengdu, Sichuan, China

Investigative Site 86009

Hangzhou, Zhejiang, China