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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE) (NCT06650852) is a Phase 2 interventional studying Chronic Hepatitis B Virus (HBV) Infection, sponsored by Brii Biosciences Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Hepatitis B Virus (HBV) Infection and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 250 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Hepatitis B Virus (HBV) Infection subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female aged 18-60 years. - Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. - Chronic HBV infection for ≥ 6 months. - On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months. - Serum ALT and AST ≤ ULN at screening visit. Who Should NOT Join This Trial: - Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study. - Significant liver fibrosis or cirrhosis. - History of clinically significant chronic liver disease from any cause other than chronic HBV infection. - History of hepatic decompensation. - Diagnosed or suspected hepatocellular carcinoma. - Current or past history of infection with HIV, HCV or HDV. - Any laboratory test abnormality that may contradict treatment with PEG-IFNα. - Known history of immunological function impairment. - History of intolerance to intramuscular or subcutaneous injection. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male or female aged 18-60 years. * Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months. * Serum ALT and AST ≤ ULN at screening visit. Exclusion Criteria: * Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study. * Significant liver fibrosis or cirrhosis. * History of clinically significant chronic liver disease from any cause other than chronic HBV infection. * History of hepatic decompensation. * Diagnosed or suspected hepatocellular carcinoma. * Current or past history of infection with HIV, HCV or HDV. * Any laboratory test abnormality that may contradict treatment with PEG-IFNα. * Known history of immunological function impairment. * History of intolerance to intramuscular or subcutaneous injection.

Treatments Being Tested

BIOLOGICAL

BRII-179

BRII-179 will be given via intramuscular injection

DRUG

BRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICAL

PEG-IFNα

PEG-IFNα will be given via subcutaneous injection

DRUG

Placebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

DRUG

Placebo of BRII-835

Placebo of BRII-835 will be given via subcutaneous injection

Locations (14)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Investigative Site 86001
Beijing, Beijing Municipality, China
Investigative Site 86003
Beijing, Beijing Municipality, China
Investigative Site 86004
Beijing, Beijing Municipality, China
Investigative Site 86005
Beijing, Beijing Municipality, China
Investigative Site 86016
Beijing, Beijing Municipality, China
Investigative Site 86002
Guangzhou, Guangdong, China
Investigative Site 86013
Guangzhou, Guangdong, China
Investigative Site 86015
Shenzhen, Guangdong, China
Investigative Site 86006
Shanghai, Shanghai Municipality, China
Investigative Site 86007
Shanghai, Shanghai Municipality, China
Investigative Site 86010
Chengdu, Sichuan, China
Investigative Site 86011
Chengdu, Sichuan, China
Investigative Site 86012
Chengdu, Sichuan, China
Investigative Site 86009
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06650852), the sponsor (Brii Biosciences Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06650852 clinical trial studying?

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06650852?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06650852?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06650852. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06650852. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.