Clinical trial NCT04749368: Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
Official title: A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Vir Biotechnology, Inc.
name: VBI Vaccines Inc.
First posted: 2021-02-11
Enrollment: 91
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 is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 - 60
* Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
* Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* Significant fibrosis or cirrhosis
* History or evidence of drug or alcohol abuse
* History of intolerance to SC or IM injection
* History of chronic liver disease from any cause other than chronic HBV infection
* History of hepatic decompensation

Primary outcomes:
measure: Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
timeFrame: up to Week 96
measure: Number of participants with Adverse Events (AE)
timeFrame: up to Week 96
measure: Number of participants with Serious Adverse Events (SAE)
timeFrame: up to Week 96
measure: Number of participants with abnormalities in clinical laboratory tests
timeFrame: up to Week 96
Secondary outcomes:
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Investigative Site 61002
state: New South Wales
city: Westmead
country: Australia
facility: Investigative Site 61001
state: New South Wales
city: Herston
country: Australia
facility: Investigative Site 61004
state: Queensland
city: Changhua, Taiwan
country: China
facility: Investigative Site 88602
city: Hongkong
country: China
facility: Investigative Site 85201
city: Hongkong
country: China
facility: Investigative Site 85202
city: Hongkong
country: China
facility: Investigative Site 85203
city: Kaohsiung, Taiwan
country: China
facility: Investigative Site 88601
city: Kaohsiung, Taiwan
country: China
facility: Investigative Site 88604
city: NEW Territories, Hong Kong
country: China
facility: Investigative Site 85204
city: Taichung, Taiwan
country: China
facility: Investigative Site 88603
city: Taipei CITY
country: China
facility: Investigative Site 88605
city: Busan
country: Korea, Republic of
facility: Investigative Site 82004
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Investigative Site 82003
city: Seoul
country: Korea, Republic of
facility: Investigative Site 82001
city: Seoul
country: Korea, Republic of
facility: Investigative Site 82005
city: Seoul
country: Korea, Republic of
facility: Investigative Site 82002
city: Dunedin Central
country: New Zealand
facility: Investigative Site 64002
state: Dunedin
city: Auckland
country: New Zealand
facility: Investigative Site 64001
city: Singapore
country: Singapore
facility: Investigative Site 65001
city: Singapore
country: Singapore
facility: Investigative Site 65002
city: Bangkok
country: Thailand
facility: Investigative Site 66001
city: Chiang Mai
country: Thailand
facility: Investigative Site 66003
city: Khon Kaen
country: Thailand
facility: Investigative Site 66002
city: Nonthaburi
country: Thailand
facility: Investigative Site 66005
city: Nonthaburi
country: Thailand
facility: Investigative Site 66006
city: Pathumthani
country: Thailand
facility: Investigative Site 66004
city: Songkhla
country: Thailand
facility: Investigative Site 66007
Study officials:
affiliation: Brii Biosciences Limited
name: Xiaofei Chen
role: STUDY_DIRECTOR
References: