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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
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
Investigative Site 86001
Beijing, Beijing Municipality, China
RECRUITINGInvestigative Site 86003
Beijing, Beijing Municipality, China
RECRUITINGInvestigative Site 86004
Beijing, Beijing Municipality, China
RECRUITINGInvestigative Site 86005
Beijing, Beijing Municipality, China
RECRUITINGInvestigative Site 86016
Beijing, Beijing Municipality, China
RECRUITINGInvestigative Site 86002
Guangzhou, Guangdong, China
RECRUITINGInvestigative Site 86013
Guangzhou, Guangdong, China
RECRUITINGInvestigative Site 86015
Shenzhen, Guangdong, China
RECRUITINGInvestigative Site 86006
Shanghai, Shanghai Municipality, China
RECRUITINGInvestigative Site 86007
Shanghai, Shanghai Municipality, China
RECRUITING...and 4 more locations
The percentage of participants achieving HBsAg seroclearance.
Time frame: Up to 48 weeks
Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: Up to 96 weeks
Percentage of participants achieving HBsAg seroconversion.
Time frame: Up to 48 weeks
Percentage of participants achieving HBsAg seroclearance.
Time frame: Up to 72 weeks
Percentage of participants achieving HBsAg seroconversion.
Time frame: Up to 72 weeks
Percentage of participants achieving functional cure.
Time frame: Up to 96 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.