Chronic Hepatitis B Virus (HBV) InfectionPhase 2NCT06650852
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 study testing BRII-179, BRII-835 (VIR-2218) and PEG-IFNα in people with Chronic Hepatitis B Virus (HBV) Infection, run by Brii Biosciences Limited at 14 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B Virus (HBV) Infection
- What is being tested?
- BRII-179, BRII-835 (VIR-2218) and PEG-IFNα
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 14 sitesChina
- Study dates
- 31 Oct 2024to Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Investigative Site 86001
Beijing, Beijing Municipality, 100000
- Recruiting
Investigative Site 86003
Beijing, Beijing Municipality, 100000
- Recruiting
Investigative Site 86004
Beijing, Beijing Municipality, 100000
- Recruiting
Investigative Site 86005
Beijing, Beijing Municipality, 100000
- Recruiting
Investigative Site 86016
Beijing, Beijing Municipality, 100000
- Recruiting
Investigative Site 86010
Chengdu, Sichuan, 610000
- Recruiting
Investigative Site 86011
Chengdu, Sichuan, 610000
- Recruiting
Investigative Site 86012
Chengdu, Sichuan, 610000
- Recruiting
Investigative Site 86002
Guangzhou, Guangdong, 510000
- Recruiting
Investigative Site 86013
Guangzhou, Guangdong, 510000
- Recruiting
Investigative Site 86009
Hangzhou, Zhejiang, 310000
- Recruiting
Investigative Site 86006
Shanghai, Shanghai Municipality, 200000
- Recruiting
Investigative Site 86007
Shanghai, Shanghai Municipality, 200000
- Recruiting
Investigative Site 86015
Shenzhen, Guangdong, 518000
About this study
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)
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.
- Being tested
- BRII-179, BRII-835 (VIR-2218), PEG-IFNα, Placebo of BRII-179, Placebo of BRII-835
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRII-179Biological
BRII-179 will be given via intramuscular injection
BRII-835 (VIR-2218)Drug
Also called elebsiran
BRII-835 will be given via subcutaneous injection
PEG-IFNαBiological
Also called Pegylated interferon alfa
PEG-IFNα will be given via subcutaneous injection
Placebo of BRII-179Drug
Placebo of BRII-179 will be given via intramuscular injection
Placebo of BRII-835Drug
Placebo of BRII-835 will be given via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1: BRII-179 + BRII-835 + PEG-IFNα | Experimental | Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1). Receives: Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα |
| Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα | Active comparator | Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα. Receives: Biological: PEG-IFNα; Drug: Placebo of BRII-179; Drug: Placebo of BRII-835 |
| Regimen 2: BRII-179 + BRII-835 + PEG-IFNα | Experimental | Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2). Receives: Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants achieving HBsAg seroclearance.
Measured: Up to 48 weeks
Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Measured: Up to 96 weeks
Secondary outcomes (4)
Percentage of participants achieving HBsAg seroconversion.
Measured: Up to 48 weeks
Percentage of participants achieving HBsAg seroclearance.
Measured: Up to 72 weeks
Percentage of participants achieving HBsAg seroconversion.
Measured: Up to 72 weeks
Percentage of participants achieving functional cure.
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start31 Oct 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus (HBV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brii Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650852
- Sponsor's protocol ID
- BRII-179-835-003
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No