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)

A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06491563

Enrollment

150

Registered

2024-07-09

Start date

2024-08-06

Completion date

2027-06-30

Last updated

2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

For Treatment of Chronic Hepatitis B Virus Infection

Brief summary

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.

Interventions

BIOLOGICALBRII-179

BRII-179 will be given via intramuscular injection

DRUGBRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICALPEG-IFNα

PEG-IFNα will be given via subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint	24 weeks post end of treatment

Secondary

Measure	Time frame
Percentage of participants with treatment-emergent adverse events (TEAEs)	24 weeks post NRTI discontinuation
Percentage of participants with serious adverse events (SAEs)	24 weeks post NRTI discontinuation
Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels)	24 weeks post end of treatment
Appearance of anti-HBs at any timepoint	24 weeks post NRTI discontinuation
Titers of anti-HBs at any timepoint	24 weeks post NRTI discontinuation
Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters	24 weeks post NRTI discontinuation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026