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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04749368




Registration number
NCT04749368
Ethics application status
Date submitted
7/02/2021
Date registered
11/02/2021

Titles & IDs
Public title
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
Scientific title
A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Secondary ID [1] 0 0
BRII-179-835-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BRII-835 (VIR-2218)
Treatment: Other - BRII-179 (VBI-2601) with IFN-a
Treatment: Other - BRII-179 (VBI-2601)

Experimental: Cohort A - Participants will receive BRII-835 (VIR-2218) for 32 weeks

Experimental: Cohort B - Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-a up to Week 40

Experimental: Cohort C - Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40


Treatment: Drugs: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection

Treatment: Other: BRII-179 (VBI-2601) with IFN-a
BRII-179 (VBI-2601) with IFN-a will be co-administered by intramuscular injection

Treatment: Other: BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
Timepoint [1] 0 0
up to Week 96
Primary outcome [2] 0 0
Number of participants with Adverse Events (AE)
Timepoint [2] 0 0
up to Week 96
Primary outcome [3] 0 0
Number of participants with Serious Adverse Events (SAE)
Timepoint [3] 0 0
up to Week 96
Primary outcome [4] 0 0
Number of participants with abnormalities in clinical laboratory tests
Timepoint [4] 0 0
up to Week 96

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2023
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Investigative Site 61002 - Kingswood
Recruitment hospital [2] 0 0
Investigative Site 61001 - Westmead
Recruitment hospital [3] 0 0
Investigative Site 61004 - Herston
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Changhua, Taiwan
Country [2] 0 0
China
State/province [2] 0 0
Hongkong
Country [3] 0 0
China
State/province [3] 0 0
Kaohsiung, Taiwan
Country [4] 0 0
China
State/province [4] 0 0
NEW Territories, Hong Kong
Country [5] 0 0
China
State/province [5] 0 0
Taichung, Taiwan
Country [6] 0 0
China
State/province [6] 0 0
Taipei CITY
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Busan
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seongnam-si, Gyeonggi-do
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
New Zealand
State/province [10] 0 0
Dunedin
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Thailand
State/province [13] 0 0
Bangkok
Country [14] 0 0
Thailand
State/province [14] 0 0
Chiang Mai
Country [15] 0 0
Thailand
State/province [15] 0 0
Khon Kaen
Country [16] 0 0
Thailand
State/province [16] 0 0
Nonthaburi
Country [17] 0 0
Thailand
State/province [17] 0 0
Pathumthani
Country [18] 0 0
Thailand
State/province [18] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Brii Biosciences Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Vir Biotechnology, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
VBI Vaccines Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Xiaofei Chen
Address 0 0
Brii Biosciences Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04749368