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

Brii Biosciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Biological: BRII-179 (VBI-2601); Biological: BRII-179 (VBI-2601) with IFN-α; Drug: BRII-835 (VIR-2218)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04749368

BRII-179-835-001

Details and patient eligibility

About

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

Enrollment: 91 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/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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Cohort A

Experimental group

Description:

Participants will receive BRII-835 (VIR-2218) for 32 weeks

Treatment:

Drug: BRII-835 (VIR-2218)

Cohort B

Experimental group

Description:

Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40

Treatment:

Drug: BRII-835 (VIR-2218)

Biological: BRII-179 (VBI-2601) with IFN-α

Cohort C

Experimental group

Description:

Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40

Treatment:

Drug: BRII-835 (VIR-2218)

Biological: BRII-179 (VBI-2601)