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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05612581




Registration number
NCT05612581
Ethics application status
Date submitted
3/11/2022
Date registered
10/11/2022
Date last updated
28/09/2023

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:
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 - VIR-3434
Treatment: Drugs - VIR-2218
Treatment: Drugs - TDF
Treatment: Drugs - PEG-IFNa

Experimental: STRIVE: Cohort 1a (VIR-3434 + TDF) - Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Experimental: STRIVE: Cohort 2a (VIR-3434 + TDF) - Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Experimental: STRIVE: Cohort 3a (VIR-3434 + TDF) - Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total

Experimental: STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) - Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total

Experimental: STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNa) - Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNa for 48 weeks total

Experimental: THRIVE: Cohort 1b (VIR-3434 + TDF) - Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks

Experimental: THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) - Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total


Treatment: Drugs: VIR-3434
VIR-3434 given by subcutaneous injection

Treatment: Drugs: VIR-2218
VIR-2218 given by subcutaneous injection

Treatment: Drugs: TDF
TDF given orally

Treatment: Drugs: PEG-IFNa
PEG-IFNa given by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
STRIVE and THRIVE: Proportion of participants achieving suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at the end of treatment
Timepoint [1] 0 0
Up to 72 weeks
Secondary outcome [1] 0 0
STRIVE and THRIVE: Proportion of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
Up to 96 weeks
Secondary outcome [2] 0 0
STRIVE and THRIVE: Proportion of participants with serum HBsAg = 10 IU/mL at end of treatment
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
STRIVE and THRIVE: Proportion of participants with serum HBsAg = 10 IU/mL at 24 weeks post-end of treatment
Timepoint [3] 0 0
Up to 72 weeks
Secondary outcome [4] 0 0
STRIVE and THRIVE: Serum HBsAg levels and change from baseline across timepoints in the study
Timepoint [4] 0 0
Up to 96 weeks
Secondary outcome [5] 0 0
STRIVE and THRIVE: Serum HBsAg level at nadir during the study
Timepoint [5] 0 0
Up to 96 weeks
Secondary outcome [6] 0 0
STRIVE and THRIVE: Time to achieve nadir of serum HBsAg during the study
Timepoint [6] 0 0
Up to 96 weeks
Secondary outcome [7] 0 0
STRIVE and THRIVE: Time to achieve serum HBsAg loss (< 0.05 IU/mL)
Timepoint [7] 0 0
Up to 96 weeks
Secondary outcome [8] 0 0
STRIVE and THRIVE: Proportion of participants with HBsAg loss with anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment
Timepoint [8] 0 0
Up to 76 weeks
Secondary outcome [9] 0 0
STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit
Timepoint [9] 0 0
Up to 96 weeks
Secondary outcome [10] 0 0
STRIVE: Proportion of participants with HBsAg loss (<0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
Timepoint [10] 0 0
Up to 72 weeks
Secondary outcome [11] 0 0
STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit
Timepoint [11] 0 0
Up to 96 weeks
Secondary outcome [12] 0 0
STRIVE: For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Timepoint [12] 0 0
Up to 72 weeks
Secondary outcome [13] 0 0
STRIVE: Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434
Timepoint [13] 0 0
Up to 96 weeks
Secondary outcome [14] 0 0
STRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
Timepoint [14] 0 0
Up to 96 weeks
Secondary outcome [15] 0 0
STRIVE: Proportion of participants achieving HBV DNA (< LLOQ) across timepoints in the study
Timepoint [15] 0 0
Up to 96 weeks
Secondary outcome [16] 0 0
STRIVE: Proportion of participants achieving ALT = ULN across timepoints in the study
Timepoint [16] 0 0
Up to 96 weeks
Secondary outcome [17] 0 0
THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at 48 weeks
Timepoint [17] 0 0
Up to 92 weeks
Secondary outcome [18] 0 0
THRIVE: Proportion of participants achieving HBsAg loss (< 0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
Timepoint [18] 0 0
Up to 44 weeks
Secondary outcome [19] 0 0
THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at 48 weeks
Timepoint [19] 0 0
Up to 68 weeks
Secondary outcome [20] 0 0
THRIVE: Incidence and titers of ADA (if applicable) to VIR-3434
Timepoint [20] 0 0
Up to 92 weeks
Secondary outcome [21] 0 0
THRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
Timepoint [21] 0 0
Up to 92 weeks
Secondary outcome [22] 0 0
THRIVE: Proportion of participants achieving HBV DNA (< LLOQ)
Timepoint [22] 0 0
Up to 92 weeks

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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
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)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Clichy
Country [2] 0 0
France
State/province [2] 0 0
Nice
Country [3] 0 0
France
State/province [3] 0 0
Rennes
Country [4] 0 0
France
State/province [4] 0 0
Toulouse
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Sha Tin
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Hong Kong
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
Seoul
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Yangsan
Country [10] 0 0
Moldova, Republic of
State/province [10] 0 0
Chisinau
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
New Zealand
State/province [12] 0 0
Hamilton
Country [13] 0 0
Romania
State/province [13] 0 0
Bucharest
Country [14] 0 0
Thailand
State/province [14] 0 0
Bangkok
Country [15] 0 0
Thailand
State/province [15] 0 0
Nonthaburi
Country [16] 0 0
Thailand
State/province [16] 0 0
Phitsanulok
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Glasgow
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester

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/ct2/show/NCT05612581
Trial related presentations / publications
Public notes

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
clinicaltrials@vir.bio
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05612581