Clinical trial NCT06491563: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: For Treatment of Chronic Hepatitis B Virus Infection
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Vir Biotechnology, Inc.
First posted: 2024-07-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female aged 18-60 years.
* 2. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* 3. Chronic HBV infection for ≥ 6 months.
* 4. On NRTI therapy for ≥ 6 months.

Exclusion Criteria:

* 1. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
* 2. Significant liver fibrosis or cirrhosis.
* 3. History or evidence of drug or alcohol abuse.
* 4. History of intolerance to SC or IM injection.
* 5. History of chronic liver disease from any cause other than chronic HBV infection.
* 6. History of hepatic decompensation.
* 7. Contraindications to the use of PEG-IFNα.

Primary outcomes:
measure: 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
timeFrame: 24 weeks post end of treatment
Secondary outcomes:
measure: 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)
timeFrame: 24 weeks post end of treatment
measure: Percentage of participants with treatment-emergent adverse events (TEAEs)
timeFrame: 24 weeks post NRTI discontinuation
measure: Percentage of participants with serious adverse events (SAEs)
timeFrame: 24 weeks post NRTI discontinuation
measure: Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters
timeFrame: 24 weeks post NRTI discontinuation
measure: Appearance of anti-HBs at any timepoint
timeFrame: 24 weeks post NRTI discontinuation
measure: Titers of anti-HBs at any timepoint
timeFrame: 24 weeks post NRTI discontinuation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigative Site 86004
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86009
state: Beijing
city: Xiamen
country: China
facility: Investigative Site 86015
state: Fujian
city: Foshan
country: China
facility: Investigative Site 86012
state: Guangdong
city: Guangzhou
country: China
facility: Investigative Site 86001
state: Guangdong
city: Guangzhou
country: China
facility: Investigative Site 86013
state: Guangdong
city: Shenzhen
country: China
facility: Investigative Site 86002
state: Guangdong
city: Shanghai
country: China
facility: Investigative Site 86003
state: Shanghai
city: Shanghai
country: China
facility: Investigative Site 86008
state: Shanghai
city: Chengdu
country: China
facility: Investigative Site 86007
state: Sichuan
city: Chengdu
country: China
facility: Investigative Site 86011
state: Sichuan
city: Hangzhou
country: China
facility: Investigative Site 86005
state: Zhejiang
Study officials:
affiliation: Brii Biosciences Limited
name: Xiaofei Chen
role: STUDY_DIRECTOR
References: