Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)
A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)
1 other identifier
interventional
150
1 country
12
Brief Summary
This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(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 Aug 2024
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 30, 2024
December 1, 2024
2.3 years
June 28, 2024
December 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint
24 weeks post end of treatment
Secondary Outcomes (6)
Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels)
24 weeks post end of treatment
Percentage of participants with treatment-emergent adverse events (TEAEs)
24 weeks post NRTI discontinuation
Percentage of participants with serious adverse events (SAEs)
24 weeks post NRTI discontinuation
Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters
24 weeks post NRTI discontinuation
Appearance of anti-HBs at any timepoint
24 weeks post NRTI discontinuation
- +1 more secondary outcomes
Study Arms (2)
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα
EXPERIMENTALParticipants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα
EXPERIMENTALParticipants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
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
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 for ≥ 6 months.
You may not qualify if:
- \. 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 or IM 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brii Biosciences Limitedlead
- Vir Biotechnology, Inc.collaborator
Study Sites (12)
Investigative Site 86004
Beijing, Beijing Municipality, 100000, China
Investigative Site 86009
Beijing, Beijing Municipality, 100000, China
Investigative Site 86015
Xiamen, Fujian, 361000, China
Investigative Site 86012
Foshan, Guangdong, 528000, China
Investigative Site 86001
Guangzhou, Guangdong, 510000, China
Investigative Site 86013
Guangzhou, Guangdong, 510000, China
Investigative Site 86002
Shenzhen, Guangdong, 518000, China
Investigative Site 86003
Shanghai, Shanghai Municipality, 200000, China
Investigative Site 86008
Shanghai, Shanghai Municipality, 200000, China
Investigative Site 86007
Chengdu, Sichuan, 610000, China
Investigative Site 86011
Chengdu, Sichuan, 610000, China
Investigative Site 86005
Hangzhou, Zhejiang, 310000, China
Study Officials
- STUDY DIRECTOR
Xiaofei Chen
Brii Biosciences Limited
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2024
First Posted
July 9, 2024
Study Start
August 6, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
December 30, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share