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 2

Active, not recruiting

• Conditions: For Treatment of Chronic Hepatitis B Virus Infection
• Interventions: Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα

• Registration Number: NCT06491563
• Lead Sponsor: Brii Biosciences Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-09
• Study Start: 2024-08-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα	BRII-179	Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα	PEG-IFNα	Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα	BRII-835 (VIR-2218)	Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα	BRII-179	Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα	BRII-835 (VIR-2218)	Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα	PEG-IFNα	Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 with abnormalities in hematology, chemistry, and/or coagulation parameters	24 weeks post NRTI discontinuation
Appearance of anti-HBs at any timepoint	24 weeks post NRTI discontinuation
Titers of anti-HBs at any timepoint	24 weeks post NRTI discontinuation

Trial Locations

Locations (12)

Investigative Site 86004; 🇨🇳 Beijing, Beijing, China

Investigative Site 86009; 🇨🇳 Beijing, Beijing, China

Investigative Site 86015; 🇨🇳 Xiamen, Fujian, China

Investigative Site 86012; 🇨🇳 Foshan, Guangdong, China

Investigative Site 86001; 🇨🇳 Guangzhou, Guangdong, China

Investigative Site 86013; 🇨🇳 Guangzhou, Guangdong, China

Investigative Site 86002; 🇨🇳 Shenzhen, Guangdong, China

Investigative Site 86003; 🇨🇳 Shanghai, Shanghai, China

Investigative Site 86008; 🇨🇳 Shanghai, Shanghai, China

Investigative Site 86007; 🇨🇳 Chengdu, Sichuan, China

Investigative Site 86011; 🇨🇳 Chengdu, Sichuan, China

Investigative Site 86005; 🇨🇳 Hangzhou, Zhejiang, China