For Treatment of Chronic Hepatitis B Virus Infection
Conditions
Brief summary
This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
Interventions
Sponsors
Brii Biosciences Limited
Vir Biotechnology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female aged 18-60 years. * 2\. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * 3\. Chronic HBV infection for ≥ 6 months. * 4\. On NRTI therapy for ≥ 6 months.
Exclusion criteria
* 1\. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * 2\. Significant liver fibrosis or cirrhosis. * 3\. History or evidence of drug or alcohol abuse. * 4\. History of intolerance to SC or IM injection. * 5\. History of chronic liver disease from any cause other than chronic HBV infection. * 6\. History of hepatic decompensation. * 7\. Contraindications to the use of PEG-IFNα.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint | 24 weeks post end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels) | 24 weeks post end of treatment |
| Percentage of participants with treatment-emergent adverse events (TEAEs) | End of Study |
| Percentage of participants with serious adverse events (SAEs) | End of Study |
| Clinical assessments including laboratory measurements | End of Study |
| Appearance of anti-HBs at any timepoint | End of Study |
| Titers of anti-HBs at any timepoint | End of Study |
Countries
China
Outcome results
None listed