Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

NCT05970289 — Phase 2, Completed, 86 participants, Brii Biosciences Limited
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A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

RegistryNCT05970289
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment86 (Actual)
SponsorBrii Biosciences Limited (Industry); collaborators: Vir Biotechnology, Inc.
ConditionsChronic Hepatitis B Virus Infection
InterventionsPEG-IFNα, BRII-835 (Biological, drug)
Datesstart 2023-08-22, primary completion 2025-07-16, completion 2026-01-23, first posted 2023-08-01, last updated 2026-10-20
Locations28 sites in Australia, China, Singapore, South Korea, Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Hepatitis B Virus Infection All trials of PEG-IFNα All trials of BRII-835

-Summary

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

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+Arms and interventions

ArmTypeInterventionsDescription
Cohort 1ExperimentalBiological: PEG-IFNαParticipants will receive multiple doses of PEG-IFNα for 48 weeks.
Cohort 2ExperimentalBiological: PEG-IFNα; Drug: BRII-835Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 3ExperimentalBiological: PEG-IFNα; Drug: BRII-835Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 4ExperimentalBiological: PEG-IFNα; Drug: BRII-835Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort).
  • PEG-IFNα (Biological), also known as pegylated interferon alfa: PEG-IFNα will be given via subcutaneous injection
  • BRII-835 (Drug): BRII-835 will be given via subcutaneous injection

+Outcome measures

Primary outcomes

  • Proportion of participants with HBsAg loss at end of treatment [Up to Week 48]
  • Proportion of participants with HBsAg loss at 24 weeks post-end of treatment [Up to Week 72]
  • Proportion of participants with treatment-emergent adverse events (TEAEs) [Up to Week 72]
  • Proportion of participants with serious adverse events (SAEs) [Up to Week 72]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* Male or female aged 18-60.
* Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* Chronic HBV infection for ≥ 6 months.
* On NRTI therapy for at least 6 months.

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
* Significant liver fibrosis or cirrhosis.
* History or evidence of drug or alcohol abuse.
* History of intolerance to SC injection.
* History of chronic liver disease from any cause other than chronic HBV infection.
* History of hepatic decompensation.
* Contraindications to the use of Peg-IFNα.

+Locations (28)

FacilityCityCountryStatus
Investigative Site 61001Kingswood, New South WalesAustralia
Investigative Site 61002Birtinya, QueenslandAustralia
Investigative Site 61003Melbourne, VictoriaAustralia
Investigative Site 86001Beijing, Beijing MunicipalityChina
Investigative Site 86007Beijing, Beijing MunicipalityChina
Investigative Site 86004Chongqing, Chongqing MunicipalityChina
Investigative Site 86006Guangzhou, GuangdongChina
Investigative Site 85201Hong Kong, HONG KONGChina
Investigative Site 85202Hong Kong, HONG KONGChina
Investigative Site 86008Changchun, JilinChina
Investigative Site 86013Shanghai, Shanghai MunicipalityChina
Investigative Site 88601Kaohsiung, TaiwanChina
Investigative Site 88602Taipei, TaiwanChina
Investigative Site 88603Taipei, TaiwanChina
Investigative Site 86011Hangzhou, ZhengjiangChina
Investigative Site 65001Singapore, SingaporeSingapore
Investigative Site 65002Singapore, SingaporeSingapore
Investigative Site 82001Busan, BusanSouth Korea
Investigative Site 82002Chuncheon, CHUNCHEON-SISouth Korea
Investigative Site 82004Daegu, DaeguSouth Korea
Investigative Site 82003Seoul, SeoulSouth Korea
Investigative Site 82005SeoulSouth Korea
Investigative Site 82006SoeulSouth Korea
Investigative Site 66003Bangkok, BangkokThailand
Investigative Site 66005Khon Kaen, Changwat Khon KaenThailand
Investigative Site 66006Nonthaburi, Changwat NonthaburiThailand
nvestigative Site 66007Chiang MaiThailand
Investigative Site 66008SongkhlaThailand

+Publications

  • Results publication: Wong GL, Yuen MF, Lin B, Douglas MW, Hu P, Xie Q, Lv F, Tak WY, Leerapun A, Kim DJ, Tangkijvanich P, Lim YS, Dai CY, O'Beirne J, Weltman M, Khemnark S, Piratvisuth T, Manasirisuk W, Chen X, Liu CJ, Heo J, Lee J, Niu J, Kumar R, Kumar R, Zhu C, Cao K, Tian A, Chen X, Zhu Q, Margolis D, Jia J, Hong Z. Elebsiran and PEG-IFNalpha for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial. Nat Med. 2026 Jan;32(1):151-159. doi: 10.1038/s41591-025-04049-z. Epub 2025 Nov 7. PMID 41203919