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)

Phase 2Active Not RecruitingNCT06491563

Brii Biosciences Limited150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

For Treatment of Chronic Hepatitis B Virus Infection

Interventions

BRII-179BIOLOGICAL

BRII-179 will be given via intramuscular injection

BRII-835 (VIR-2218)DRUG

BRII-835 will be given via subcutaneous injection

PEG-IFNαBIOLOGICAL

PEG-IFNα will be given via subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (12)

Investigative Site 86004

Beijing, Beijing Municipality, China

Investigative Site 86009

Beijing, Beijing Municipality, China

Investigative Site 86015

Xiamen, Fujian, China

Outcomes

Primary Outcomes

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

Time frame: 24 weeks post end of treatment

Secondary Outcomes

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)

Time frame: 24 weeks post end of treatment

Percentage of participants with treatment-emergent adverse events (TEAEs)