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)
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)
1 other identifier
interventional
250
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
May 23, 2025
May 1, 2025
1.7 years
October 12, 2024
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
The percentage of participants achieving HBsAg seroclearance.
Up to 48 weeks
Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Up to 96 weeks
Secondary Outcomes (4)
Percentage of participants achieving HBsAg seroconversion.
Up to 48 weeks
Percentage of participants achieving HBsAg seroclearance.
Up to 72 weeks
Percentage of participants achieving HBsAg seroconversion.
Up to 72 weeks
Percentage of participants achieving functional cure.
Up to 96 weeks
Study Arms (3)
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
EXPERIMENTALParticipants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
ACTIVE COMPARATORParticipants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
EXPERIMENTALParticipants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
Interventions
BRII-179 will be given via intramuscular injection
BRII-835 will be given via subcutaneous injection
PEG-IFNα will be given via subcutaneous injection
Placebo of BRII-179 will be given via intramuscular injection
Placebo of BRII-835 will be given via subcutaneous injection
Eligibility Criteria
You may qualify if:
- Male or female aged 18-60 years.
- Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
- Chronic HBV infection for ≥ 6 months.
- On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months.
- Serum ALT and AST ≤ ULN at screening visit.
You may not qualify if:
- Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
- Significant liver fibrosis or cirrhosis.
- History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
- History of hepatic decompensation.
- Diagnosed or suspected hepatocellular carcinoma.
- Current or past history of infection with HIV, HCV or HDV.
- Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
- Known history of immunological function impairment.
- History of intolerance to intramuscular or subcutaneous injection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Investigative Site 86001
Beijing, Beijing Municipality, 100000, China
Investigative Site 86003
Beijing, Beijing Municipality, 100000, China
Investigative Site 86004
Beijing, Beijing Municipality, 100000, China
Investigative Site 86005
Beijing, Beijing Municipality, 100000, China
Investigative Site 86016
Beijing, Beijing Municipality, 100000, China
Investigative Site 86002
Guangzhou, Guangdong, 510000, China
Investigative Site 86013
Guangzhou, Guangdong, 510000, China
Investigative Site 86015
Shenzhen, Guangdong, 518000, China
Investigative Site 86006
Shanghai, Shanghai Municipality, 200000, China
Investigative Site 86007
Shanghai, Shanghai Municipality, 200000, China
Investigative Site 86010
Chengdu, Sichuan, 610000, China
Investigative Site 86011
Chengdu, Sichuan, 610000, China
Investigative Site 86012
Chengdu, Sichuan, 610000, China
Investigative Site 86009
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaofei Chen
Brii Biosciences Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2024
First Posted
October 21, 2024
Study Start
October 31, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share