Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
21/03/2024

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
This study will evaluate the efficacy and safety of PEG-IFNa alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
Trial website
https://clinicaltrials.gov/study/NCT05970289
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05970289