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Trial registered on ANZCTR
Registration number
ACTRN12619001210167
Ethics application status
Approved
Date submitted
9/07/2019
Date registered
30/08/2019
Date last updated
1/10/2019
Date data sharing statement initially provided
30/08/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among
Subjects with Chronic Hepatitis B
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Scientific title
A Phase Ib/IIa Randomized, Controlled Dose Escalation Study to Evaluate
Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among
Subjects with Chronic Hepatitis B
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Secondary ID [1]
298651
0
BRII-179-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B virus (HBV) infection
313541
0
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Condition category
Condition code
Infection
311971
311971
0
0
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Other infectious diseases
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Oral and Gastrointestinal
311972
311972
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BRII-179 (VBI-2601) given by intramuscular injection.
A qualified study site staff member under the supervision of the investigator of designee will administer study drug to participants via IM injection.
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Intervention code [1]
314914
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Treatment: Drugs
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Comparator / control treatment
Active control group; Cohort A will continue taking their nucleotide/nucleoside regimen as per normal.
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Control group
Active
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Outcomes
Primary outcome [1]
320623
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Number of subjects with Adverse Events as assessed by CTCAE v5.0
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Timepoint [1]
320623
0
Monitored throughout the study: during screening, Day 1, Day 2, Day 7, Day 28, Day 35, Day 56, Day 63, Day 84, Day 91, Day 112, Day 140 and Day 168.
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Secondary outcome [1]
372247
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Antiviral activity of BRII-179 (VBI-2601). Outcome is assessed by measurement of viral markers, e.g., HBsAg, anti-HBs, HBeAg, anti-HBe, with serum assays and it is a composite secondary outcome
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Timepoint [1]
372247
0
Monitored at Weeks 4, 8, 12, 16, 20 and 24.
Timepoints of assessment of this outcome: Post enrolment and Post-treatment
Its treatment completion (EOS), then week followed by 4,8,12, 24 are post enrolment.
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Secondary outcome [2]
372248
0
Pharmacodynamic effect of BRII-179 (VBI-2601). Outcome is assessed by measurement of biomarkers of immune responses with serum and blood cellular assays, and it is a composite secondary outcome
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Timepoint [2]
372248
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Monitored at Weeks 4, 8, 12, 16, 20 and 24.
Timepoints of assessment of this outcome: post-treatment
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Eligibility
Key inclusion criteria
1) Male or female age 18 to 60
2) BMI 18 to 32 kg per meter 2
3) Chronic HBV infection for greater than or equal 6 months
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Minimum age
18
Years
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Maximum age
60
Years
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
2) Significant fibrosis or cirrhosis
3) History or evidence of drug or alcohol abuse
4) History of intolerance to intramuscular injection
5) History of chronic liver disease from any cause other than chronic HBV infection
6) History of hepatic decompensation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint(s)
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/09/2019
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Actual
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Date of last participant enrolment
Anticipated
31/03/2020
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Actual
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Date of last data collection
Anticipated
30/09/2020
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Actual
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Sample size
Target
65
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment outside Australia
Country [1]
21664
0
Korea, Republic Of
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State/province [1]
21664
0
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Country [2]
21665
0
Thailand
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State/province [2]
21665
0
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Country [3]
21666
0
New Zealand
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State/province [3]
21666
0
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Country [4]
21667
0
China
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State/province [4]
21667
0
Hong Kong
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Funding & Sponsors
Funding source category [1]
303189
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Commercial sector/Industry
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Name [1]
303189
0
Brii Biosciences
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Address [1]
303189
0
Room 301, 3/F,
Building 7,
No. 1 Yongtaizhuang North Street,
Haidian District, Beijing
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Country [1]
303189
0
China
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Primary sponsor type
Commercial sector/Industry
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Name
Brii Biosciences
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Address
Room 301, 3/F,
Building 7,
No. 1 Yongtaizhuang North Street,
Haidian District, Beijing
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Country
China
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Secondary sponsor category [1]
303203
0
None
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Name [1]
303203
0
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Address [1]
303203
0
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Country [1]
303203
0
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Other collaborator category [1]
280832
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Commercial sector/Industry
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Name [1]
280832
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Novotech (Australia) Pty Limited
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Address [1]
280832
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Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
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Country [1]
280832
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303753
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
303753
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Ministry of Health, 133 Molesworth Street, PO Box 5013, Wellington, 6011
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Ethics committee country [1]
303753
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New Zealand
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Date submitted for ethics approval [1]
303753
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25/06/2019
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Approval date [1]
303753
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26/08/2019
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Ethics approval number [1]
303753
0
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Summary
Brief summary
This is a phase 1/2 study in which subjects with chronic HBV infection will receive BRII-179 (VBI-2601) and will be assessed for safety, tolerability antiviral activity and pharmacodynamic effects.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
94674
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Dr Tien Huey Lim
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Address
94674
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Middlemore Clinical Trials, Esme Green Building, 100 Hospital Road, Papatoetoe, Auckland, New Zealand, 1640
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Country
94674
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New Zealand
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Phone
94674
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+64 9 2760044
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Fax
94674
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Email
94674
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TienHuey.Lim@middlemore.co.nz
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Contact person for public queries
Name
94675
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Dr Yao Zhang
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Address
94675
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Beijing Yintai Centre Tower C, Suite 3115
No. 2 Jianguomenwai Ave., Chaoyang District
Beijing, PRC
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Country
94675
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China
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Phone
94675
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+86 18600094236
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Fax
94675
0
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Email
94675
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yao.zhang@briibio.com
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Contact person for scientific queries
Name
94676
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Dr Yao Zhang
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Address
94676
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Beijing Yintai Centre Tower C, Suite 3115
No. 2 Jianguomenwai Ave., Chaoyang District
Beijing, PRC
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Country
94676
0
China
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Phone
94676
0
+86 18600094236
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Fax
94676
0
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Email
94676
0
yao.zhang@briibio.com
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No other documents available
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Summary results
No Results
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