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

Brii Biosciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Hepatitis B Virus Infection

Treatments: Biological: PEG-IFNα; Drug: BRII-835

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970289

BRII-835-002

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Participants will receive multiple doses of PEG-IFNα for 48 weeks.

Treatment:

Biological: PEG-IFNα

Cohort 2

Experimental group

Description:

Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.

Treatment:

Drug: BRII-835

Biological: PEG-IFNα

Cohort 3

Experimental group

Description:

Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.

Treatment:

Drug: BRII-835

Biological: PEG-IFNα

Cohort 4

Experimental group

Description:

Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort).

Treatment:

Drug: BRII-835

Biological: PEG-IFNα