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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05970289




Registration number
NCT05970289
Ethics application status
Date submitted
21/07/2023
Date registered
1/08/2023

Titles & IDs
Public title
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNa Combination Therapy in Chronic HBV Patients
Scientific title
A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNa) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Secondary ID [1] 0 0
BRII-835-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
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: Other - PEG-IFNa
Treatment: Drugs - BRII-835

Experimental: Cohort 1 - Participants will receive multiple doses of PEG-IFNa for 48 weeks.

Experimental: Cohort 2 - Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNa for 48 weeks.

Experimental: Cohort 3 - Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNa for 48 weeks.

Experimental: Cohort 4 - Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNa for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort).


Treatment: Other: PEG-IFNa
PEG-IFNa will be given via subcutaneous injection

Treatment: Drugs: BRII-835
BRII-835 will be given via subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with HBsAg loss at end of treatment
Timepoint [1] 0 0
Up to Week 48
Primary outcome [2] 0 0
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Timepoint [2] 0 0
Up to Week 72
Primary outcome [3] 0 0
Proportion of participants with treatment-emergent adverse events (TEAEs)
Timepoint [3] 0 0
Up to Week 72
Primary outcome [4] 0 0
Proportion of participants with serious adverse events (SAEs)
Timepoint [4] 0 0
Up to Week 72

Eligibility
Key inclusion criteria
* Male or female aged 18-60.
* Body mass index = 18 kg/m2 and = 32 kg/m2.
* Chronic HBV infection for = 6 months.
* On NRTI therapy for at least 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 participant unsuitable for participation.
* Significant liver fibrosis or cirrhosis.
* History or evidence of drug or alcohol abuse.
* History of intolerance to SC injection.
* History of chronic liver disease from any cause other than chronic HBV infection.
* History of hepatic decompensation.
* Contraindications to the use of Peg-IFNa.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site 61001 - Kingswood
Recruitment hospital [2] 0 0
Investigative Site 61002 - Birtinya
Recruitment hospital [3] 0 0
Investigative Site 61003 - Melbourne
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Chongqing
Country [3] 0 0
China
State/province [3] 0 0
Guangdong
Country [4] 0 0
China
State/province [4] 0 0
Hong Kong
Country [5] 0 0
China
State/province [5] 0 0
Jilin
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
China
State/province [7] 0 0
Taiwan
Country [8] 0 0
China
State/province [8] 0 0
Zhengjiang
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Busan
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Chuncheon-si
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Daegu
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Soeul
Country [14] 0 0
Singapore
State/province [14] 0 0
Singapore
Country [15] 0 0
Thailand
State/province [15] 0 0
Bangkok
Country [16] 0 0
Thailand
State/province [16] 0 0
Chiang Mai
Country [17] 0 0
Thailand
State/province [17] 0 0
Khon Kaen
Country [18] 0 0
Thailand
State/province [18] 0 0
Nonthaburi
Country [19] 0 0
Thailand
State/province [19] 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

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/NCT05970289