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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRII-179, BRII-835 (VIR-2218), PEG-IFNα, Placebo of BRII-179.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis B Virus (HBV) Infection. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- 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
Primary outcome measures
- The percentage of participants achieving HBsAg seroclearance. [Time frame: Up to 48 weeks]
- Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). [Time frame: Up to 96 weeks]
Secondary outcome measures (4)
- Percentage of participants achieving HBsAg seroconversion. [Time frame: Up to 48 weeks]
- Percentage of participants achieving HBsAg seroclearance. [Time frame: Up to 72 weeks]
- Percentage of participants achieving HBsAg seroconversion. [Time frame: Up to 72 weeks]
- Percentage of participants achieving functional cure. [Time frame: Up to 96 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 14 centers
- Investigative Site 86001 — Beijing
- Investigative Site 86003 — Beijing
- Investigative Site 86004 — Beijing
- Investigative Site 86005 — Beijing
- Investigative Site 86016 — Beijing
- Investigative Site 86002 — Guangzhou
- Investigative Site 86013 — Guangzhou
- Investigative Site 86015 — Shenzhen
- … and 6 more centers
Identifiers
NCT: NCT06650852 · BRII-179-835-003