Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

Brii Biosciences

Status and phase: Active, not recruiting; Phase 2

Conditions: For Treatment of Chronic Hepatitis B Virus Infection

Treatments: Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα

Study type: Interventional

Funder types: Industry

Identifiers

NCT06491563

BRII-179-835-002

Details and patient eligibility

About

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Male or female aged 18-60 years.
• 2. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
• 3. Chronic HBV infection for ≥ 6 months.
• 4. On NRTI therapy for ≥ 6 months.

Exclusion criteria

• 1. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
• 2. Significant liver fibrosis or cirrhosis.
• 3. History or evidence of drug or alcohol abuse.
• 4. History of intolerance to SC or IM injection.
• 5. History of chronic liver disease from any cause other than chronic HBV infection.
• 6. History of hepatic decompensation.
• 7. Contraindications to the use of PEG-IFNα.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα

Experimental group

Description:

Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

Treatment:

Biological: PEG-IFNα

Drug: BRII-835 (VIR-2218)

Biological: BRII-179

BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα

Experimental group

Description:

Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

Treatment:

Biological: PEG-IFNα

Drug: BRII-835 (VIR-2218)

Biological: BRII-179