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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
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Scientific title
A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)
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Secondary ID [1]
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VIR-MHB1-V200
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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STRIVE and THRIVE: Proportion of participants achieving suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at the end of treatment
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Assessment method [1]
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Timepoint [1]
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Up to 72 weeks
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Secondary outcome [1]
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STRIVE and THRIVE: Proportion of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
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Assessment method [1]
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Timepoint [1]
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Up to 96 weeks
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Secondary outcome [2]
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STRIVE and THRIVE: Proportion of participants with serum HBsAg = 10 IU/mL at end of treatment
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Assessment method [2]
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Timepoint [2]
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Up to 48 weeks
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Secondary outcome [3]
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STRIVE and THRIVE: Proportion of participants with serum HBsAg = 10 IU/mL at 24 weeks post-end of treatment
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Assessment method [3]
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Timepoint [3]
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Up to 72 weeks
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Secondary outcome [4]
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STRIVE and THRIVE: Serum HBsAg levels and change from baseline across timepoints in the study
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Assessment method [4]
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Timepoint [4]
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Up to 96 weeks
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Secondary outcome [5]
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STRIVE and THRIVE: Serum HBsAg level at nadir during the study
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Assessment method [5]
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Timepoint [5]
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Up to 96 weeks
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Secondary outcome [6]
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STRIVE and THRIVE: Time to achieve nadir of serum HBsAg during the study
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Assessment method [6]
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Timepoint [6]
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Up to 96 weeks
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Secondary outcome [7]
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STRIVE and THRIVE: Time to achieve serum HBsAg loss (< 0.05 IU/mL)
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Assessment method [7]
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Timepoint [7]
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Up to 96 weeks
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Secondary outcome [8]
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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
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Assessment method [8]
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Timepoint [8]
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Up to 76 weeks
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Secondary outcome [9]
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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
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Assessment method [9]
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Timepoint [9]
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Up to 96 weeks
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Secondary outcome [10]
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STRIVE: Proportion of participants with HBsAg loss (<0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
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Assessment method [10]
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Timepoint [10]
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Up to 72 weeks
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Secondary outcome [11]
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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
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Assessment method [11]
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Timepoint [11]
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Up to 96 weeks
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Secondary outcome [12]
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STRIVE: For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
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Assessment method [12]
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Timepoint [12]
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Up to 72 weeks
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Secondary outcome [13]
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STRIVE: Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434
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Assessment method [13]
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Timepoint [13]
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Up to 96 weeks
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Secondary outcome [14]
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STRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
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Assessment method [14]
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Timepoint [14]
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Up to 96 weeks
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Secondary outcome [15]
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STRIVE: Proportion of participants achieving HBV DNA (< LLOQ) across timepoints in the study
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Assessment method [15]
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Timepoint [15]
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Up to 96 weeks
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Secondary outcome [16]
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STRIVE: Proportion of participants achieving ALT = ULN across timepoints in the study
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Assessment method [16]
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Timepoint [16]
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Up to 96 weeks
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Secondary outcome [17]
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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
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Assessment method [17]
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Timepoint [17]
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Up to 92 weeks
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Secondary outcome [18]
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THRIVE: Proportion of participants achieving HBsAg loss (< 0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
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Assessment method [18]
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Timepoint [18]
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Up to 44 weeks
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Secondary outcome [19]
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THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at 48 weeks
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Assessment method [19]
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Timepoint [19]
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Up to 68 weeks
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Secondary outcome [20]
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THRIVE: Incidence and titers of ADA (if applicable) to VIR-3434
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Assessment method [20]
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Timepoint [20]
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Up to 92 weeks
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Secondary outcome [21]
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THRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
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Assessment method [21]
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Timepoint [21]
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Up to 92 weeks
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Secondary outcome [22]
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THRIVE: Proportion of participants achieving HBV DNA (< LLOQ)
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Assessment method [22]
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Timepoint [22]
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Up to 92 weeks
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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
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Minimum age
18
Years
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Maximum age
66
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2027
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Clichy
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Country [2]
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France
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State/province [2]
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Nice
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Country [3]
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France
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State/province [3]
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Rennes
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Country [4]
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France
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State/province [4]
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Toulouse
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Country [5]
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Hong Kong
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State/province [5]
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Sha Tin
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Country [6]
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Hong Kong
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State/province [6]
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Hong Kong
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Country [7]
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Korea, Republic of
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State/province [7]
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Busan
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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Korea, Republic of
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State/province [9]
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Yangsan
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Country [10]
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Moldova, Republic of
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State/province [10]
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Chisinau
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Country [11]
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New Zealand
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State/province [11]
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Auckland
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Country [12]
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New Zealand
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State/province [12]
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Hamilton
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Country [13]
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Romania
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State/province [13]
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Bucharest
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Country [14]
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Thailand
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State/province [14]
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Bangkok
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Country [15]
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Thailand
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State/province [15]
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Nonthaburi
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Country [16]
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Thailand
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State/province [16]
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Phitsanulok
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Country [17]
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United Kingdom
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State/province [17]
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Glasgow
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Country [18]
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United Kingdom
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State/province [18]
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London
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Country [19]
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United Kingdom
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State/province [19]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vir Biotechnology, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05612581
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Inquiry
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Address
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Country
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Phone
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415-654-5281
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05612581
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