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)

NCT06491563 — Phase 2, Completed, 150 participants, Brii Biosciences Limited

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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)

Registry	NCT06491563
Status	Completed
Phase	Phase 2
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	150 (Actual)
Sponsor	Brii Biosciences Limited (Industry); collaborators: Vir Biotechnology, Inc.
Conditions	For Treatment of Chronic Hepatitis B Virus Infection
Interventions	BRII-179, BRII-835 (VIR-2218), PEG-IFNα (Biological, drug)
Dates	start 2024-08-06, primary completion 2026-08-05, completion 2026-08-05, first posted 2024-07-09, last updated 2026-10-21
Locations	12 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα	Experimental	Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα	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	Experimental	Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα	Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.

BRII-179 (Biological): BRII-179 will be given via intramuscular injection
BRII-835 (VIR-2218) (Drug), also known as elebsiran: BRII-835 will be given via subcutaneous injection
PEG-IFNα (Biological), also known as Pegylated interferon alfa: PEG-IFNα will be given via subcutaneous injection

+Outcome measures

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 [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) [24 weeks post end of treatment]
Percentage of participants with treatment-emergent adverse events (TEAEs) [End of Study]
Percentage of participants with serious adverse events (SAEs) [End of Study]
Clinical assessments including laboratory measurements [End of Study]
Appearance of anti-HBs at any timepoint [End of Study]
Titers of anti-HBs at any timepoint [End of Study]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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)

Facility	City	Country
Investigative Site 86004	Beijing, Beijing Municipality	China
Investigative Site 86009	Beijing, Beijing Municipality	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 Municipality	China
Investigative Site 86008	Shanghai, Shanghai Municipality	China
Investigative Site 86007	Chengdu, Sichuan	China
Investigative Site 86011	Chengdu, Sichuan	China
Investigative Site 86005	Hangzhou, Zhejiang	China