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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
BRII-835 (VIR-2218) will be given by subcutaneous injection
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
BRII-179 (VBI-2601) will be administered by intramuscular injection
Investigative Site 61002
Kingswood, New South Wales, Australia
Percentage of Participants With Sustained HBsAg Loss During the 48-week Follow-up Period After NRTI Withdrawal
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
Time frame: Up to Week 96
Number of Participants With Adverse Events (AE)
Treatment-emergent adverse events (TEAEs) were summarized for each cohort
Time frame: Up to Week 96
Number of Participants With Serious Adverse Events (SAE)
Serious adverse events (SAEs) were summarized for each cohort
Time frame: Up to Week 96
Number of Participants With Abnormalities in Clinical Laboratory Tests
Treatment-emergent laboratory abnormalities of at least grade 3 are summarized for each cohort
Time frame: Up to Week 96
Percentage of Participants Meeting the NRTI Withdrawal Criteria at Week 44
Percentage of participants meeting the NRTI withdrawal criteria at Week 44 was summarized for each cohort
Time frame: Week 44
Percentage of Participants With HBsAg Loss With or Without Antibodies to Hepatitis B Surface Antigen (Anti-HBs) at 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
Time frame: Week 72
Percentage of Participants With HBsAg Loss at Any Timepoint
Percentage of participants with HBsAg loss at any timepoint was summarized for each cohort
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Investigative Site 61001
Westmead, New South Wales, Australia
Investigative Site 61004
Herston, Queensland, Australia
Investigative Site 88602
Changhua, Taiwan, China
Investigative Site 85201
Hong Kong, China
Investigative Site 85202
Hong Kong, China
Investigative Site 85203
Hong Kong, China
Investigative Site 88601
Kaohsiung, Taiwan, China
Investigative Site 88604
Kaohsiung, Taiwan, China
Investigative Site 85204
NEW Territories, Hong Kong, China
...and 18 more locations
Time frame: Up to Week 72
Percentage of Participants With HBsAg Seroconversion at Any Timepoint
Percentage of participants with HBsAg seroconversion at any timepoint was summarized for each cohort
Time frame: Up to Week 72
Change From Baseline in Serum HBsAg at Week 72
Change from baseline in serum HBsAg at Week 72 was summarized for each cohort
Time frame: Week 72
Percentage of Participants With HBeAg Loss and/or Anti-HBe Seroconversion at Week 44 in Those Who Were HBeAg Positive at Screening
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
Time frame: Week 44
Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint
Change from baseline in serum appearance and/or titer of anti-HBs at any timepoint was summarized for each cohort
Time frame: Up to Week 72