Clinical trial NCT05970289: Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
Official title: A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Hepatitis B Virus Infection
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Vir Biotechnology, Inc.
First posted: 2023-08-01
Enrollment: 75
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 study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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 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.

Primary outcomes:
measure: Proportion of participants with HBsAg loss at end of treatment
timeFrame: Up to Week 48
measure: Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
timeFrame: Up to Week 72
measure: Proportion of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to Week 72
measure: Proportion of participants with serious adverse events (SAEs)
timeFrame: Up to Week 72
Secondary outcomes:
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Investigative Site 61001
state: New South Wales
city: Birtinya
country: Australia
facility: Investigative Site 61002
state: Queensland
city: Melbourne
country: Australia
facility: Investigative Site 61003
state: Victoria
city: Beijing
country: China
facility: Investigative Site 86001
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86001
state: Beijing
city: Beijing
country: China
facility: Investigative Site 86007
state: Beijing
city: Chongqing
country: China
facility: Investigative Site 86004
state: Chongqing
city: Guangzhou
country: China
facility: Investigative Site 86006
state: Guangdong
city: Hong Kong
country: China
facility: Investigative Site 85201
state: Hong Kong
city: Hong Kong
country: China
facility: Investigative Site 85202
state: Hong Kong
city: Changchun
country: China
facility: Investigative Site 86008
state: Jilin
city: Shanghai
country: China
facility: Investigative Site 86013
state: Shanghai
city: Kaohsiung
country: China
facility: Investigative Site 88601
state: Taiwan
city: Taipei
country: China
facility: Investigative Site 88602
state: Taiwan
city: Taipei
country: China
facility: Investigative Site 88603
state: Taiwan
city: Hangzhou
country: China
facility: Investigative Site 86011
state: Zhengjiang
city: Busan
country: Korea, Republic of
facility: Investigative Site 82001
city: Chuncheon-si
country: Korea, Republic of
facility: Investigative Site 82002
city: Daegu
country: Korea, Republic of
facility: Investigative Site 82004
city: Seoul
country: Korea, Republic of
facility: Investigative Site 82005
city: Seoul
country: Korea, Republic of
facility: Investigative Site 82003
city: Soeul
country: Korea, Republic of
facility: Investigative Site 82006
city: Singapore
country: Singapore
facility: Investigative Site 65001
city: Singapore
country: Singapore
facility: Investigative Site 65002
city: Bangkok
country: Thailand
facility: Investigative Site 66003
city: Chiang Mai
country: Thailand
facility: nvestigative Site 66007
city: Khon Kaen
country: Thailand
facility: Investigative Site 66005
city: Nonthaburi
country: Thailand
facility: Investigative Site 66006
city: Songkhla
country: Thailand
facility: Investigative Site 66008
Study officials:
affiliation: Brii Biosciences Limited
name: Xiaofei Chen
role: STUDY_DIRECTOR
References: