Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Brief summary
This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection
Interventions
BRII-835 (VIR-2218) will be given by subcutaneous injection
BIOLOGICALBRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
BIOLOGICALBRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection
Sponsors
Brii Biosciences Limited
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 - 60 * Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2 * Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months
Exclusion criteria
* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * Significant fibrosis or cirrhosis * History or evidence of drug or alcohol abuse * History of intolerance to SC or IM injection * History of chronic liver disease from any cause other than chronic HBV infection * History of hepatic decompensation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained HBsAg Loss During the 48-week Follow-up Period After NRTI Withdrawal | Up to Week 96 | Sustained HBsAg loss was defined as undetectable HBsAg \< 0.05 IU/mL for at least 24 weeks during the 48-week follow-up period after NRTI withdrawal |
| Number of Participants With Adverse Events (AE) | Up to Week 96 | Treatment-emergent adverse events (TEAEs) were summarized for each cohort |
| Number of Participants With Serious Adverse Events (SAE) | Up to Week 96 | Serious adverse events (SAEs) were summarized for each cohort |
| Number of Participants With Abnormalities in Clinical Laboratory Tests | Up to Week 96 | Treatment-emergent laboratory abnormalities of at least grade 3 are summarized for each cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting the NRTI Withdrawal Criteria at Week 44 | Week 44 | Percentage of participants meeting the NRTI withdrawal criteria at Week 44 was summarized for each cohort |
| Percentage of Participants With HBsAg Loss With or Without Antibodies to Hepatitis B Surface Antigen (Anti-HBs) at Week 72 | Week 72 | Percentage of participants with HBsAg loss with or without antibodies to hepatitis B surface antigen (anti-HBs) at Week 72 was summarized for each cohort |
| Percentage of Participants With HBsAg Loss at Any Timepoint | Up to Week 72 | Percentage of participants with HBsAg loss at any timepoint was summarized for each cohort |
| Percentage of Participants With HBsAg Seroconversion at Any Timepoint | Up to Week 72 | Percentage of participants with HBsAg seroconversion at any timepoint was summarized for each cohort |
| Change From Baseline in Serum HBsAg at Week 72 | Week 72 | Change from baseline in serum HBsAg at Week 72 was summarized for each cohort |
| Percentage of Participants With HBeAg Loss and/or Anti-HBe Seroconversion at Week 44 in Those Who Were HBeAg Positive at Screening | Week 44 | Percentage of participants with HBeAg loss and/or anti-HBe seroconversion at Week 44 in those who were HBeAg positive at screening was summarized for each cohort |
| Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint | Up to Week 72 | Change from baseline in serum appearance and/or titer of anti-HBs at any timepoint was summarized for each cohort |
Countries
Australia, China, New Zealand, Singapore, South Korea, Thailand
Contacts
STUDY_DIRECTORXiaofei Chen
Brii Biosciences Limited
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 8.07 |
| ALT at screening | 26.8 U/L STANDARD_DEVIATION 14.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HBeAg at screening Negative | 31 Participants |
| HBeAg at screening Positive | 10 Participants |
| HBsAg at screening | 2.918 log10 IU/mL STANDARD_DEVIATION 0.337 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 39 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 39 | 0 / 41 |
| other Total, other adverse events | 10 / 10 | 37 / 39 | 37 / 41 |
| serious Total, serious adverse events | 0 / 10 | 3 / 39 | 6 / 41 |
Outcome results
None listed