Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749368
• Other study ID #: BRII-179-835-001
• Status: Completed
• Phase: Phase 2
• Start date: April 12, 2021
• Est. completion date: July 4, 2023

Study information

• Verified date: June 2024
• Source: Brii Biosciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 4, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection

Biological:
• BRII-179 (VBI-2601) with IFN-a
BRII-179 (VBI-2601) with IFN-a will be co-administered by intramuscular injection
• BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection

Locations

Country	Name	City	State
Australia	Investigative Site 61004	Herston	Queensland
Australia	Investigative Site 61002	Kingswood	New South Wales
Australia	Investigative Site 61001	Westmead	New South Wales
China	Investigative Site 88602	Changhua, Taiwan
China	Investigative Site 85201	Hongkong
China	Investigative Site 85202	Hongkong
China	Investigative Site 85203	Hongkong
China	Investigative Site 88601	Kaohsiung, Taiwan
China	Investigative Site 88604	Kaohsiung, Taiwan
China	Investigative Site 85204	NEW Territories, Hong Kong
China	Investigative Site 88603	Taichung, Taiwan
China	Investigative Site 88605	Taipei CITY
Korea, Republic of	Investigative Site 82004	Busan
Korea, Republic of	Investigative Site 82003	Seongnam-si, Gyeonggi-do
Korea, Republic of	Investigative Site 82001	Seoul
Korea, Republic of	Investigative Site 82002	Seoul
Korea, Republic of	Investigative Site 82005	Seoul
New Zealand	Investigative Site 64001	Auckland
New Zealand	Investigative Site 64002	Dunedin Central	Dunedin
Singapore	Investigative Site 65001	Singapore
Singapore	Investigative Site 65002	Singapore
Thailand	Investigative Site 66001	Bangkok
Thailand	Investigative Site 66003	Chiang Mai
Thailand	Investigative Site 66002	Khon Kaen
Thailand	Investigative Site 66005	Nonthaburi
Thailand	Investigative Site 66006	Nonthaburi
Thailand	Investigative Site 66004	Pathumthani
Thailand	Investigative Site 66007	Songkhla

Sponsors (3)

Lead Sponsor	Collaborator
Brii Biosciences Limited	VBI Vaccines Inc., Vir Biotechnology, Inc.

Countries where clinical trial is conducted

Australia,  China,  Korea, Republic of,  New Zealand,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal		up to Week 96
Primary	Number of participants with Adverse Events (AE)		up to Week 96
Primary	Number of participants with Serious Adverse Events (SAE)		up to Week 96
Primary	Number of participants with abnormalities in clinical laboratory tests		up to Week 96