Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Chronic Hepatitis B Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05970289
• Other study ID #: BRII-835-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 22, 2023
• Est. completion date: February 2026

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: February 2026
• Est. primary completion date: August 2025
• 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/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-IFNa.

Related Conditions & MeSH terms

• Chronic Hepatitis B Virus Infection
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Infections

Intervention

Biological:
• PEG-IFNa
PEG-IFNa will be given via subcutaneous injection

Drug:
• BRII-835
BRII-835 will be given via subcutaneous injection

Locations

Country	Name	City	State
Australia	Investigative Site 61002	Birtinya	Queensland
Australia	Investigative Site 61001	Kingswood	New South Wales
Australia	Investigative Site 61003	Melbourne	Victoria
China	Investigative Site 86001	Beijing	Beijing
China	Investigative Site 86001	Beijing	Beijing
China	Investigative Site 86007	Beijing	Beijing
China	Investigative Site 86008	Changchun	Jilin
China	Investigative Site 86004	Chongqing	Chongqing
China	Investigative Site 86006	Guangzhou	Guangdong
China	Investigative Site 86011	Hangzhou	Zhengjiang
China	Investigative Site 85201	Hong Kong	Hong Kong
China	Investigative Site 85202	Hong Kong	Hong Kong
China	Investigative Site 88601	Kaohsiung	Taiwan
China	Investigative Site 86013	Shanghai	Shanghai
China	Investigative Site 88602	Taipei	Taiwan
China	Investigative Site 88603	Taipei	Taiwan
Korea, Republic of	Investigative Site 82001	Busan
Korea, Republic of	Investigative Site 82002	Chuncheon-si
Korea, Republic of	Investigative Site 82004	Daegu
Korea, Republic of	Investigative Site 82003	Seoul
Korea, Republic of	Investigative Site 82005	Seoul
Korea, Republic of	Investigative Site 82006	Soeul
Singapore	Investigative Site 65001	Singapore
Singapore	Investigative Site 65002	Singapore
Thailand	Investigative Site 66003	Bangkok
Thailand	nvestigative Site 66007	Chiang Mai
Thailand	Investigative Site 66005	Khon Kaen
Thailand	Investigative Site 66006	Nonthaburi
Thailand	Investigative Site 66008	Songkhla

Sponsors (2)

Lead Sponsor	Collaborator
Brii Biosciences Limited	Vir Biotechnology, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with HBsAg loss at end of treatment		Up to Week 48
Primary	Proportion of participants with HBsAg loss at 24 weeks post-end of treatment		Up to Week 72
Primary	Proportion of participants with treatment-emergent adverse events (TEAEs)		Up to Week 72
Primary	Proportion of participants with serious adverse events (SAEs)		Up to Week 72