Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05612581




Registration number
NCT05612581
Ethics application status
Date submitted
3/11/2022
Date registered
10/11/2022
Date last updated
20/02/2024

Titles & IDs
Public title
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
Scientific title
A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)
Secondary ID [1] 0 0
VIR-MHB1-V200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: ADG206 dose escalation -

Experimental: SHR-1921 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
Timepoint [1] 0 0
Day 0

Eligibility
Key inclusion criteria
* Male or female ages 18 or older
* Chronic HBV infection for >/= 6 months
* Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation
* STRIVE: HBeAg positive or negative, HBV DNA > 2,000 IU/mL, ALT > ULN and = 5x ULN
* THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA = 2,000 IU/mL, ALT = ULN
Minimum age
18 Years
Maximum age
66 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
* History of clinically significant liver disease from non-HBV etiology
* History or current evidence of hepatic decompensation
* Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
* History or clinical evidence of alcohol or drug abuse
* STRIVE and THRIVE: Significant fibrosis or cirrhosis
* STRIVE and THRIVE: History of immune complex disease
* STRIVE and THRIVE: History of autoimmune disorder
* STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
* STRIVE: Prior NRTI or PEG-IFN therapy
* STRIVE: History of known contraindication to any interferon product
* THRIVE: Prior NRTI therapy < 24 weeks of study or any prior PEG-IFN therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 1
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
10/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.
Trial website
https://clinicaltrials.gov/study/NCT05612581
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Inquiry
Address 0 0
Country 0 0
Phone 0 0
415-654-5281
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05612581