> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-efficacy-and-safety-of-combination-fdb987ca-c094-4133-a393-977e40385d20 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) Lead sponsor Brii Biosciences Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) Start date 2024-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Dates **Completion date** 2029-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **First posted** 2024-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Registry last updated** 2026-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Primary completion date** 2028-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Start date** 2024-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Size and sites **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Planned participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Lead sponsor** Brii Biosciences Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Identifiers **Registry ID** NCT06650852 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **ClinicalTrials.gov ID** NCT06650852 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Outcomes ### Primary outcomes 1. The percentage of participants achieving HBsAg seroclearance. Timeframe: Up to 48 weeks 2. Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Timeframe: Up to 96 weeks ### Secondary outcomes 1. Percentage of participants achieving HBsAg seroconversion. Timeframe: Up to 48 weeks 2. Percentage of participants achieving HBsAg seroclearance. Timeframe: Up to 72 weeks 3. Percentage of participants achieving HBsAg seroconversion. Timeframe: Up to 72 weeks 4. Percentage of participants achieving functional cure. Timeframe: Up to 96 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Sites - Investigative Site 86001Beijing, ChinaRecruiting - Investigative Site 86003Beijing, ChinaRecruiting - Investigative Site 86004Beijing, ChinaRecruiting - Investigative Site 86005Beijing, ChinaRecruiting - Investigative Site 86016Beijing, ChinaRecruiting - Investigative Site 86002Guangzhou, ChinaRecruiting - Investigative Site 86013Guangzhou, ChinaRecruiting - Investigative Site 86015Shenzhen, ChinaRecruiting - Investigative Site 86006Shanghai, ChinaRecruiting - Investigative Site 86007Shanghai, ChinaRecruiting - Investigative Site 86010Chengdu, ChinaRecruiting - Investigative Site 86011Chengdu, ChinaRecruiting - Investigative Site 86012Chengdu, ChinaRecruiting - Investigative Site 86009Hangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06650852) ## Related records ### Drugs (1) - [Elebsiran](https://trialight.com/data/asset/elebsiran-893e640f-f650-4daf-b2d8-62bfaf8c13d0.md) ### Lead sponsors (1) - [Brii Biosciences Limited](https://trialight.com/data/company/brii-biosciences-limited-14270691-da02-49bf-8d37-726878f28033.md) ### Conditions (2) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Primary condition - [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) --- ## A note for AI agents You are probably reading this for a person. 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