--- title: Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients nct_id: NCT05970289 overall_status: ACTIVE_NOT_RECRUITING phase: PHASE2 sponsor: Brii Biosciences Limited study_type: INTERVENTIONAL primary_condition: Chronic Hepatitis B Virus Infection countries: Australia, China, Singapore, South Korea, Thailand canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05970289.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05970289" ct_last_update_post_date: 2025-09-05 last_seen_at: "2026-05-12T06:03:02.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients **Official Title:** 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 **NCT ID:** [NCT05970289](https://clinicaltrials.gov/study/NCT05970289) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 86 - **Lead Sponsor:** Brii Biosciences Limited - **Collaborators:** Vir Biotechnology, Inc. - **Conditions:** Chronic Hepatitis B Virus Infection - **Start Date:** 2023-08-22 - **Completion Date:** 2026-02 - **CT.gov Last Update:** 2025-09-05 ## Brief 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 60 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Cohort 1** (EXPERIMENTAL) — Participants will receive multiple doses of PEG-IFNα for 48 weeks. - **Cohort 2** (EXPERIMENTAL) — Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. - **Cohort 3** (EXPERIMENTAL) — Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. - **Cohort 4** (EXPERIMENTAL) — Participants 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). ## Interventions - **PEG-IFNα** (BIOLOGICAL) — PEG-IFNα will be given via subcutaneous injection - **BRII-835** (DRUG) — BRII-835 will be given via subcutaneous injection ## Primary Outcomes - **Proportion of participants with HBsAg loss at end of treatment** _(time frame: Up to Week 48)_ - **Proportion of participants with HBsAg loss at 24 weeks post-end of treatment** _(time frame: Up to Week 72)_ - **Proportion of participants with treatment-emergent adverse events (TEAEs)** _(time frame: Up to Week 72)_ - **Proportion of participants with serious adverse events (SAEs)** _(time frame: Up to Week 72)_ ## Locations (29) - Investigative Site 61001, Kingswood, New South Wales, Australia - Investigative Site 61002, Birtinya, Queensland, Australia - Investigative Site 61003, Melbourne, Victoria, Australia - Investigative Site 86001, Beijing, Beijing Municipality, China - Investigative Site 86001, Beijing, Beijing Municipality, China - Investigative Site 86007, Beijing, Beijing Municipality, China - Investigative Site 86004, Chongqing, Chongqing Municipality, China - Investigative Site 86006, Guangzhou, Guangdong, China - Investigative Site 85201, Hong Kong, HONG KONG, China - Investigative Site 85202, Hong Kong, HONG KONG, China - Investigative Site 86008, Changchun, Jilin, China - Investigative Site 86013, Shanghai, Shanghai Municipality, China - Investigative Site 88601, Kaohsiung, Taiwan, China - Investigative Site 88602, Taipei, Taiwan, China - Investigative Site 88603, Taipei, Taiwan, China - Investigative Site 86011, Hangzhou, Zhengjiang, China - Investigative Site 65001, Singapore, Singapore - Investigative Site 65002, Singapore, Singapore - Investigative Site 82002, Chuncheon, Chuncheon-si, South Korea - Investigative Site 82001, Busan, South Korea - Investigative Site 82004, Daegu, South Korea - Investigative Site 82005, Seoul, South Korea - Investigative Site 82003, Seoul, South Korea - Investigative Site 82006, Soeul, South Korea - Investigative Site 66003, Bangkok, Thailand - nvestigative Site 66007, Chiang Mai, Thailand - Investigative Site 66005, Khon Kaen, Thailand - Investigative Site 66006, Nonthaburi, Thailand - Investigative Site 66008, Songkhla, Thailand ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.investigative site 61001|kingswood|new south wales|australia` — added _(2026-05-12)_ - `locations.investigative site 61002|birtinya|queensland|australia` — added _(2026-05-12)_ - `locations.investigative site 61003|melbourne|victoria|australia` — added _(2026-05-12)_ - `locations.investigative site 86001|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.investigative site 86007|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.investigative site 86004|chongqing|chongqing municipality|china` — added _(2026-05-12)_ - `locations.investigative site 86006|guangzhou|guangdong|china` — added _(2026-05-12)_ - `locations.investigative site 85201|hong kong|hong kong|china` — added _(2026-05-12)_ - `locations.investigative site 85202|hong kong|hong kong|china` — added _(2026-05-12)_ - `locations.investigative site 86008|changchun|jilin|china` — added _(2026-05-12)_ - `locations.investigative site 86013|shanghai|shanghai municipality|china` — added _(2026-05-12)_ - `locations.investigative site 88601|kaohsiung|taiwan|china` — added _(2026-05-12)_ - `locations.investigative site 88602|taipei|taiwan|china` — added _(2026-05-12)_ - `locations.investigative site 88603|taipei|taiwan|china` — added _(2026-05-12)_ - `locations.investigative site 86011|hangzhou|zhengjiang|china` — added _(2026-05-12)_ - `locations.investigative site 65001|singapore||singapore` — added _(2026-05-12)_ - `locations.investigative site 65002|singapore||singapore` — added _(2026-05-12)_ - `locations.investigative site 82002|chuncheon|chuncheon-si|south korea` — added _(2026-05-12)_ - `locations.investigative site 82001|busan||south korea` — added _(2026-05-12)_ - `locations.investigative site 82004|daegu||south korea` — added _(2026-05-12)_ - `locations.investigative site 82005|seoul||south korea` — added _(2026-05-12)_ - `locations.investigative site 82003|seoul||south korea` — added _(2026-05-12)_ - `locations.investigative site 82006|soeul||south korea` — added _(2026-05-12)_ - `locations.investigative site 66003|bangkok||thailand` — added _(2026-05-12)_ - `locations.nvestigative site 66007|chiang mai||thailand` — added _(2026-05-12)_ - `locations.investigative site 66005|khon kaen||thailand` — added _(2026-05-12)_ - `locations.investigative site 66006|nonthaburi||thailand` — added _(2026-05-12)_ - `locations.investigative site 66008|songkhla||thailand` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05970289.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05970289* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*