Clinical trial NCT06650852: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Hepatitis B Virus (HBV) Infection
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The percentage of participants achieving HBsAg seroclearance.
timeFrame: Up to 48 weeks
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
timeFrame: Up to 96 weeks
Secondary outcomes:
measure: Percentage of participants achieving HBsAg seroconversion.
timeFrame: Up to 48 weeks
measure: Percentage of participants achieving HBsAg seroclearance.
timeFrame: Up to 72 weeks
measure: Percentage of participants achieving HBsAg seroconversion.
timeFrame: Up to 72 weeks
measure: Percentage of participants achieving functional cure.
timeFrame: Up to 96 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigative Site 86001
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86003
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86004
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86005
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86016
state: Beijing
city: Guangzhou
country: China
facility: Investigative Site 86002
state: Guangdong
city: Guangzhou
country: China
facility: Investigative Site 86013
state: Guangdong
city: Shenzhen
country: China
facility: Investigative Site 86015
state: Guangdong
city: Shanghai
country: China
facility: Investigative Site 86006
state: Shanghai
city: Shanghai
country: China
facility: Investigative Site 86007
state: Shanghai
city: Chengdu
country: China
facility: Investigative Site 86010
state: Sichuan
city: Chengdu
country: China
facility: Investigative Site 86011
state: Sichuan
city: Chengdu
country: China
facility: Investigative Site 86012
state: Sichuan
city: Hangzhou
country: China
facility: Investigative Site 86009
state: Zhejiang
Study officials:
affiliation: Brii Biosciences Limited
name: Xiaofei Chen
role: STUDY_DIRECTOR
References: