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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)
Led by Brii Biosciences Limited · Updated on 2025-05-23
250
Participants Needed
14
Research Sites
139 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-60 years
- Body mass index between 18 and 32 kg/m2
- Chronic HBV infection for at least 6 months
- On NRTI therapy with HBV DNA below lower limit of quantification for at least 6 months
- Serum ALT and AST at or below upper limit of normal at screening
You will not qualify if you...
- Any significant chronic medical condition other than chronic HBV making participation unsuitable
- Significant liver fibrosis or cirrhosis
- History of chronic liver disease other than chronic HBV
- History of hepatic decompensation
- Diagnosed or suspected hepatocellular carcinoma
- Current or past infection with HIV, HCV, or HDV
- Laboratory abnormalities contraindicating PEG-IFNα treatment
- Known immunological function impairment
- History of intolerance to intramuscular or subcutaneous injections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Investigative Site 86001
Beijing, Beijing Municipality, China, 100000
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2
Investigative Site 86003
Beijing, Beijing Municipality, China, 100000
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3
Investigative Site 86004
Beijing, Beijing Municipality, China, 100000
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4
Investigative Site 86005
Beijing, Beijing Municipality, China, 100000
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5
Investigative Site 86016
Beijing, Beijing Municipality, China, 100000
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6
Investigative Site 86002
Guangzhou, Guangdong, China, 510000
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7
Investigative Site 86013
Guangzhou, Guangdong, China, 510000
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8
Investigative Site 86015
Shenzhen, Guangdong, China, 518000
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9
Investigative Site 86006
Shanghai, Shanghai Municipality, China, 200000
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10
Investigative Site 86007
Shanghai, Shanghai Municipality, China, 200000
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11
Investigative Site 86010
Chengdu, Sichuan, China, 610000
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12
Investigative Site 86011
Chengdu, Sichuan, China, 610000
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13
Investigative Site 86012
Chengdu, Sichuan, China, 610000
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14
Investigative Site 86009
Hangzhou, Zhejiang, China, 310000
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Research Team
C
Clinical Research, Brii Biosciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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