Chronic Hepatitis BPhase 1NCT04423393

Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection

A Phase 1 study testing VIR-3434 in people with Chronic Hepatitis B, run by Vir Biotechnology, Inc. at 24 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV infection). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Hepatitis B
What is being tested?: VIR-3434
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 113 participants
Where: 24 sitesin 7 countries
Study dates: 26 May 2020to 25 Nov 2022
Phase: Phase 1
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female age 18 - 55
Weight 40-125 kg
Male or female age 18 - 65
Weight 40-125 kg
Chronic HBV infection for >/= 6 months

Who cannot join

Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
History or evidence of drug or alcohol abuse
History of allergic reactions to monoclonal antibodies or antibody fragments
History of anaphylaxis
CHB Patients:
Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation

Show all 14Show fewer

Significant fibrosis or cirrhosis
History or evidence of drug or alcohol abuse
History of chronic liver disease from any cause other than chronic HBV infection
History of hepatic decompensation
History of anaphylaxis
History of allergic reactions to monoclonal antibodies or antibody fragments
History of immune complex disease
Active infection with HIV, HCV or hepatitis Delta virus

Trial locations and contacts

24 sites in 7 countries.

Country

City, postcode or hospital

24 sites in 7 countries

Germany7 sites

Investigative Site
Essen, 45147
Investigative Site
Frankfurt, 60590
Investigative Site
Hanover, 30625
Investigative Site
Leipzig, 04103
Investigative Site
Mainz, 55131
Investigative Site
Mannheim, 68167
Investigative Site
Ulm, 89081

Other trials in Germany

South Korea6 sites

Investigative Site
Busan, 47392
Investigative Site
Busan, 49241
Investigative Site
Seoul, 02841
Investigative Site
Seoul, 03080
Investigative Site
Seoul, 05505
Investigative Site
Seoul, 06273

Other trials in South Korea

New Zealand4 sites

Investigative Site
Auckland, 1010
Investigative Site
Havelock North, 4130
Investigative Site
Newtown, 6021
Investigative Site
Tauranga, 3110

Other trials in New Zealand

United Kingdom3 sites

Investigative Site
Birmingham, B15 2TT
Investigative Site
London, E1 2EF
Investigative Site
Manchester, M8 5RB

Other trials in United Kingdom

Singapore2 sites

Investigative Site
Singapore, 169608
Investigative Site
Singapore, 529889

Other trials in Singapore

Hong Kong1 site

Investigative Site
Hong Kong

Other trials in Hong Kong

Romania1 site

Investigative Site
Bucharest

Other trials in Romania

About this study

Official title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434

Conditions: Chronic Hepatitis B
Being tested: VIR-3434, Placebo
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-3434Biological
VIR-3434 given by subcutaneous injection or intravenous infusion.
PlaceboOther
Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.

Study groups in NCT04423393
Study group	Role	What they receive
VIR-3434	Experimental	Not described Receives: Biological: VIR-3434
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities
Measured: Up to 280 days post-dose

Secondary outcomes (14)

Cmax
VIR-3434 Maximum Concentration in Serum
Measured: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Tmax
VIR-3434 time of Cmax in Serum
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
AUClast
VIR-3434 under the curve from time 0 to last measurable Time
Measured: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
t1/2
VIR-3434 apparent Elimination Half-life (t1/2) in serum
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Vz/F
VIR-3434 Volume of Distribution (SC only)
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Vz
VIR-3434 Volume of Distribution (IV only)
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
CL/F
VIR-3434 Apparent serum clearance (SC only)
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
CL
VIR-3434 Apparent serum clearance (IV only)
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
Number of Participants With ADA to VIR-3434
Evaluate the immunogenicity of VIR-3434
Measured: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)
HBsAg reductions at nadir and Week 4
Measured: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)
HBV DNA reductions at nadir and Week 4
Measured: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Titers (if Applicable) of ADA to VIR-3434
Evaluate the immunogenicity of VIR-3434
Measured: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
Cmax
VIR-3434 Maximum Concentration in Serum
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
AUClast
VIR-3434 under the curve from time 0 to last measurable Time
Measured: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 202025 Nov 2022

First posted9 Jun 2020
Study start26 May 2020
Primary completion24 Oct 2022
Study completion25 Nov 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis BStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04423393
Sponsor's protocol ID: VIR-3434-1002
Other IDs: 2019-003837-40, 2019
Status last verified: Sep 2024
First submitted: 25 May 2020
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Vincenzetti L, Wong R, Marzi R, Guarino B, Stefanutti E, Gupta SV, Rosen LE, Belnap DM, Wang L, Chen YP, di Iulio J, Momin A, Tracy KE, Deshpande S, Errico JM, Giovannoni F, Sprugasci N, Peter A, Seu L, Cloutier D, Tay CH, Snell G, Czudnochowski N, Lempp FA, Havenar-Daughton C, Benigni F, Lanzavecchia A, Agarwal K, Yuen MF, Wedemeyer H, Gane E, Arvin A, Corti D, Schmid MA. Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells. J Hepatol. 2026 Jan;84(1):62-73. doi: 10.1016/j.jhep.2025.08.016. Epub 2025 Aug 27.
PubMed 40882923

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434
ClinicalTrials.gov ID: NCT04423393
Acronym / sponsor ID: VIR-3434-1002
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
Study start: 26 May 2020 (actual)
Primary completion: 24 Oct 2022 (actual)
Study completion: 25 Nov 2022 (actual)
First posted: 9 Jun 2020 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VIR-3434	Experimental	Biological: VIR-3434
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female age 18 - 55
Weight 40-125 kg
Male or female age 18 - 65
Weight 40-125 kg
Chronic HBV infection for >/= 6 months

Key exclusion criteria (14 listed)

Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
History or evidence of drug or alcohol abuse
History of allergic reactions to monoclonal antibodies or antibody fragments
History of anaphylaxis
Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation

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-3434VIR-3434 given by subcutaneous injection or intravenous infusion.	Biological	VIR-3434
PlaceboSterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.	Other	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to 280 days post-dose

14 secondary outcomes

Cmax
Time frame: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Tmax
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
AUClast
Time frame: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
t1/2
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Vz/F
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Vz
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
CL/F
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
CL
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
Number of Participants With ADA to VIR-3434
Time frame: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)
Time frame: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)
Time frame: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Titers (if Applicable) of ADA to VIR-3434
Time frame: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose
Cmax
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose
AUClast
Time frame: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Healthy Participants 90 mg SC	6	6
Part A Healthy Participants 300 mg SC	6	6
Part A Healthy Participants 900 mg SC	6	6
Part A Healthy Participants 900 mg IV	6	6
Part A: Healthy Participants 3000 mg IV	6	6
Part A Healthy Participants Placebo	11	10
Part B: HBV Participants 6 mg SC	6	6
Part B: HBV Participants 18 mg SC	6	6
Part B: HBV Participants 75 mg SC	6	6
Part B: HBV Participants 300 mg SC	6	6
Part B: HBV Participants Placebo	8	8
Part C: HBV Participants 18 mg SC	6	6
Part C: HBV Participants 75 mg SC	6	6
Part C: HBV Participants 300 mg SC	6	4
Part C: HBV Participants Placebo	6	6
Part D: HBV Participants 75 mg SC	6	6
Part D: HBV Participants 300 mg SC	6	6
Part D: HBV Participants Placebo	4	4

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D. Count of participants. Unit: Participants

Measure	Part A: Healthy Participants 90 mg SC n = 6	Part A Healthy Participants 300 mg SC n = 6	Part A Healthy Participants 900 mg SC n = 6	Part A Healthy Participants 900 mg IV n = 6	Part A: Healthy Participants 3000 mg IV n = 6	Part A Healthy Participants Placebo n = 11	Part B: HBV Participants 6 mg SC n = 6	Part B: HBV Participants 18 mg SC n = 6	Part B: HBV Participants 75 mg SC n = 6	Part B: HBV Participants 300 mg SC n = 6	Part B: HBV Participants Placebo n = 8	Part C: HBV Participants 18 mg SC n = 6	Part C: HBV Participants 75 mg SC n = 6	Part C: HBV Participants 300 mg SC n = 6	Part C: HBV Participants Placebo n = 6	Part D: HBV Participants 75 mg SC n = 6	Part D: HBV Participants 300 mg SC n = 6	Part D: HBV Participants Placebo n = 4
Value	5	4	5	4	3	6	2	4	3	3	2	2	4	5	4	2	6	3

Primary outcome: Number of Participants With Clinical Laboratory Abnormalities

Time frame: Up to 280 days post-dose. Count of participants. Unit: Participants

Measure	Part A Healthy Participants 300 mg SC n = 6	Part A Healthy Participants 900 mg SC n = 6	Part A: Healthy Participants 3000 mg IV n = 6	Part A Healthy Participants Placebo n = 11	Part B: HBV Participants 6 mg SC n = 6	Part B: HBV Participants 18 mg SC n = 6	Part B: HBV Participants 75 mg SC n = 6	Part B: HBV Participants 300 mg SC n = 6	Part B: HBV Participants Placebo n = 8	Part C: HBV Participants 18 mg SC n = 6	Part C: HBV Participants 75 mg SC n = 6	Part C: HBV Participants 300 mg SC n = 6	Part C: HBV Participants Placebo n = 6	Part D: HBV Participants 75 mg SC n = 6	Part D: HBV Participants 300 mg SC n = 6	Part D: HBV Participants Placebo n = 4
ALT Grade 1	1	1	2	0	0	0	1	0	0	0	1	0	0	0	5	0
ALT Grade 2	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
ALT Grade 3	0	0	0

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Healthy Participants 90 mg SC	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part A Healthy Participants 300 mg SC	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part A Healthy Participants 900 mg SC	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part A Healthy Participants 900 mg IV	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part A: Healthy Participants 3000 mg IV	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part A Healthy Participants Placebo	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
Part B: HBV Participants 6 mg SC	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part B: HBV Participants 18 mg SC	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part B: HBV Participants 75 mg SC	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part B: HBV Participants 300 mg SC	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part B: HBV Participants Placebo	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Part C: HBV Participants 18 mg SC	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part C: HBV Participants 75 mg SC	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part C: HBV Participants 300 mg SC	1 of 6 (16.7%)	5 of 6 (83.3%)	0 of 6
Part C: HBV Participants Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part D: HBV Participants 75 mg SC	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part D: HBV Participants 300 mg SC	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part D: HBV Participants Placebo	0 of 4 (0%)	1 of 4 (25%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40882923Vincenzetti L, Wong R, Marzi R, Guarino B, Stefanutti E, Gupta SV, Rosen LE, Belnap DM, Wang L, Chen YP, di Iulio J, Momin A, Tracy KE, Deshpande S, Errico JM, Giovannoni F, Sprugasci N, Peter A, Seu L, Cloutier D, Tay CH, Snell G, Czudnochowski N, Lempp FA, Havenar-Daughton C, Benigni F, Lanzavecchia A, Agarwal K, Yuen MF, Wedemeyer H, Gane E, Arvin A, Corti D, Schmid MA. Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells. J Hepatol. 2026 Jan;84(1):62-73. doi: 10.1016/j.jhep.2025.08.016. Epub 2025 Aug 27.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis B

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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.

24 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VIR-3434 in people with Chronic Hepatitis B, run by Vir Biotechnology, Inc. at 24 sites in 7 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 14 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, South Korea, New Zealand, United Kingdom, Singapore and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 8 Oct 2024). 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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04423393, which also lists 1 linked publication.

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 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.