Hepatitis B, ChronicPhase 1/2NCT05612581
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
A Phase 1/2 study testing VIR-3434, VIR-2218 and TDF in people with Hepatitis B, Chronic, run by Vir Biotechnology, Inc. at 15 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- VIR-3434, VIR-2218 and TDF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 10 May 2023to 19 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
France4 sites
Investigative Site
Clichy, 92110
Investigative Site
Nice, 06200
Investigative Site
Rennes, 35000
Investigative Site
Toulouse, 31000
United Kingdom4 sites
Investigative Site
Glasgow, G4 0SF
Investigative Site
London, EC1A 7BE
Investigative Site
London, SE5 9RS
Investigative Site
Manchester, M8 5RB
South Korea3 sites
Investigative Site
Busan, 49241
Investigative Site
Seoul, 5505
Investigative Site
Yangsan, 50612
Hong Kong2 sites
Investigative Site
Hong Kong, Sha Tin
Investigative Site
Hong Kong
About this study
Official title: A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)
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.
Read the detailed description
VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment.
VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.
- Conditions
- Hepatitis B, Chronic
- Being tested
- VIR-3434, VIR-2218, TDF, PEG-IFNα
- Keywords
- Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-3434Drug
Also called Tobevibart
VIR-3434 given by subcutaneous injection
VIR-2218Drug
Also called Elebsiran
VIR-2218 given by subcutaneous injection
TDFDrug
TDF given orally
PEG-IFNαDrug
PEG-IFNα given by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| STRIVE: Cohort 1a (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total Receives: Drug: VIR-3434; Drug: TDF |
| STRIVE: Cohort 2a (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total Receives: Drug: VIR-3434; Drug: TDF |
| STRIVE: Cohort 3a (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total Receives: Drug: VIR-3434; Drug: TDF |
| STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total Receives: Drug: VIR-3434; Drug: VIR-2218; Drug: TDF |
| STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | Experimental | Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total Receives: Drug: VIR-3434; Drug: VIR-2218; Drug: TDF; Drug: PEG-IFNα |
| THRIVE: Cohort 1b (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks Receives: Drug: VIR-3434; Drug: TDF |
| THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total Receives: Drug: VIR-3434; Drug: VIR-2218; Drug: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment
Measured: Up to 48 weeks
Secondary outcomes (22)
STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 96 weeks
STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment
Measured: Up to 48 weeks
STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment
Measured: Up to 72 weeks
STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study
Measured: Up to 96 weeks
STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study
Measured: Up to 96 weeks
STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study
Measured: Up to 96 weeks
STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL)
Measured: Up to 96 weeks
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
Measured: Up to 76 weeks
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
Measured: Up to 96 weeks
STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment
Measured: Up to 72 weeks
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
Measured: Up to 96 weeks
STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion
Measured: Up to 72 weeks
STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434
Measured: Up to 96 weeks
STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study
Measured: Up to 96 weeks
STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study
Measured: Up to 96 weeks
STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study
Measured: Up to 96 weeks
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
Measured: Up to 92 weeks
THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment
Measured: Up to 44 weeks
THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks
Measured: Up to 68 weeks
THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434
Measured: Up to 92 weeks
THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study
Measured: Up to 92 weeks
THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ)
Measured: Up to 92 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start10 May 2023
- Primary completion15 Oct 2024
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612581
- Sponsor's protocol ID
- VIR-MHB1-V200
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2022
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)
- ClinicalTrials.gov ID
- NCT05612581
- Acronym / sponsor ID
- VIR-MHB1-V200
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment.
VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| STRIVE: Cohort 1a (VIR-3434 + TDF) | Experimental | Drug: VIR-3434, Drug: TDFParticipants will receive combination therapy with VIR-3434 + TDF for 44 weeks total |
| STRIVE: Cohort 2a (VIR-3434 + TDF) | Experimental | Drug: VIR-3434, Drug: TDFParticipants will receive combination therapy with VIR-3434 + TDF for 44 weeks total |
| STRIVE: Cohort 3a (VIR-3434 + TDF) | Experimental | Drug: VIR-3434, Drug: TDFParticipants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total |
| STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | Experimental | Drug: VIR-3434, Drug: VIR-2218, Drug: TDFParticipants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total |
| STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | Experimental | Drug: VIR-3434, Drug: VIR-2218, Drug: TDF, Drug: PEG-IFNαParticipants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total |
| THRIVE: Cohort 1b (VIR-3434 + TDF) | Experimental | Drug: VIR-3434, Drug: TDFParticipants will receive combination therapy with VIR-3434 + TDF for 44 weeks |
| THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | Experimental | Drug: VIR-3434, Drug: VIR-2218, Drug: TDFParticipants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIR-3434Also: TobevibartVIR-3434 given by subcutaneous injection | Drug | STRIVE: Cohort 1a (VIR-3434 + TDF), STRIVE: Cohort 2a (VIR-3434 + TDF), STRIVE: Cohort 3a (VIR-3434 + TDF), STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF), STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα), THRIVE: Cohort 1b (VIR-3434 + TDF), THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) |
| VIR-2218Also: ElebsiranVIR-2218 given by subcutaneous injection | Drug | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF), STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα), THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) |
| TDFTDF given orally | Drug | STRIVE: Cohort 1a (VIR-3434 + TDF), STRIVE: Cohort 2a (VIR-3434 + TDF), STRIVE: Cohort 3a (VIR-3434 + TDF), STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF), STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα), THRIVE: Cohort 1b (VIR-3434 + TDF), THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) |
| PEG-IFNαPEG-IFNα given by subcutaneous injection | Drug | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) |
Primary outcome
STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment
Time frame: Up to 48 weeks
22 secondary outcomes
STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 96 weeks
STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment
Time frame: Up to 48 weeks
STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment
Time frame: Up to 72 weeks
STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study
Time frame: Up to 96 weeks
STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study
Time frame: Up to 96 weeks
STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study
Time frame: Up to 96 weeks
STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL)
Time frame: Up to 96 weeks
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
Time frame: Up to 76 weeks
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
Time frame: Up to 96 weeks
STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment
Time frame: Up to 72 weeks
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
Time frame: Up to 96 weeks
STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion
Time frame: Up to 72 weeks
STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434
Time frame: Up to 96 weeks
STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study
Time frame: Up to 96 weeks
STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study
Time frame: Up to 96 weeks
STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study
Time frame: Up to 96 weeks
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
Time frame: Up to 92 weeks
THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment
Time frame: Up to 44 weeks
THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks
Time frame: Up to 68 weeks
THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434
Time frame: Up to 92 weeks
THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study
Time frame: Up to 92 weeks
THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ)
Time frame: Up to 92 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VIR-3434, VIR-2218 and TDF in people with Hepatitis B, Chronic, run by Vir Biotechnology, Inc. at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, United Kingdom, South Korea, Hong Kong, Moldova and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.