Viral HepatitisPhase 2NCT07142811
A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection
A Phase 2 study testing Tobevibart, Elebsiran and Bulevirtide in people with Viral Hepatitis, run by Vir Biotechnology, Inc. at 31 sites in 11 countries.
Trial summary
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Viral Hepatitis
- What is being tested?
- Tobevibart, Elebsiran and Bulevirtide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 31 sitesin 11 countries
- Study dates
- 5 Aug 2025to Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ages 18 to 70 years at screening
- Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
- Noncirrhotic or compensated cirrhotic liver disease at screening
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 10 IU/ml at screening, currently on locally approved NRTI therapy
Who cannot join
- Serum ALT ≥ 5 × ULN
- Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
- History of significant liver disease from non-HBV or non-HDV etiology
- History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
- History of anaphylaxis
- History of immune complex disease
Show all 9Show fewer
- History of autoimmune disorder
- Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
- Any previous treatment with Bulivertide
Trial locations and contacts
31 sites in 11 countries.
31 sites in 11 countries
France5 sites
Investigative Site
Clichy, 92110
Investigative Site
Créteil, 94000
Investigative Site
Limoges, 87042
Investigative Site
Rennes, 35000
Investigative Site
Toulouse, 31059
Pakistan4 sites
Investigative Site
Karachi, 74800
Investigative Site
Karachi, 75600
Investigative Site
Lahore, 54800
Investigative Site
Rawalpindi, 46000
United Kingdom4 sites
Investigative Site
London, E1 1BB
Investigative Site
London, SE5 9RS
Investigative Site
Manchester, M8 5RB
Investigative Site
Nottingham, NG7 2UH
Belgium3 sites
Investigative Site
Brussels, 1020
Investigative Site
Brussels, 1070
Investigative Site
Edegem, 2650
Bulgaria3 sites
Investigative Site
Sofia, 1407
Investigative Site
Sofia, 1431
Investigative Site
Stara Zagora, 6003
Netherlands3 sites
Investigative Site
Amsterdam, 1081 HV
Investigative Site
Nijmegen, 6525 GA
Investigative Site
Rotterdam, 3015 GD
Romania3 sites
Investigative Site
Bucharest, 021105
Investigative Site
Bucharest, 022328
Investigative Site
Bucharest, 030303
Spain3 sites
Investigative Site
Barcelona, 08028
Investigative Site
Madrid, 28064
Investigative
Valencia, 46014
About this study
Official title: A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
- Conditions
- Viral Hepatitis
- Being tested
- Tobevibart, Elebsiran, Bulevirtide
- Keywords
- HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus, Digestive System Diseases, Liver Diseases
- Medical subject headings
- Hepatitis, Hepatitis D, Hepatitis D, Chronic, Digestive System Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobevibartDrug
Also called VIR-3434
Tobevibart administered by subcutaneous injection
ElebsiranDrug
Also called VIR-2218
Elebsiran administered by subcutaneous injection
BulevirtideDrug
Also called Hepcludex
Bulevirtide administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive treatment with tobevibart + elebsiran up to 240 weeks. Receives: Drug: Tobevibart; Drug: Elebsiran |
| Arm 2 | Experimental | Participants will receive Bulevirtide for approximately 48 weeks and switch to receive tobevibart + elebsiran for additional 192 weeks Receives: Drug: Tobevibart; Drug: Elebsiran; Drug: Bulevirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48
Measured: Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment
Measured: 24 Weeks after End of Treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48
Measured: Week 48
Secondary outcomes (5)
Change from baseline in HDV RNA at Week 48
Measured: Week 48
Change from baseline in ALT at Week 48
Measured: Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 96, Week 120, Week 144, Week 192 and Week 240
Measured: Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in HDV RNA at Week 96, Week 120, Week 144, Week 192 and Week 240
Measured: Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 96, Week 120, Week 144, Week 192 and Week 240
Measured: Week 96 to Week 120, Week 144, Week 192 and Week 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start5 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral HepatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142811
- Sponsor's protocol ID
- VIR-CHDV-V206
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Noack J, Anglero-Rodriguez Y, Gall J, Zhou J, LeBlanc S, Liebow A, Bakardjiev A, Hebner CM, Purcell LA, Jadhav V, Corti D, Lempp FA. Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0112725. doi: 10.1128/aac.01127-25. Epub 2026 Jan 26.
PubMed 41586499
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)
- ClinicalTrials.gov ID
- NCT07142811
- Acronym / sponsor ID
- VIR-CHDV-V206
- Conditions
- Viral Hepatitis
- Keywords
- HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus, Digestive System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Tobevibart, Drug: ElebsiranParticipants will receive treatment with tobevibart + elebsiran up to 240 weeks. |
| Arm 2 | Experimental | Drug: Tobevibart, Drug: Elebsiran, Drug: BulevirtideParticipants will receive Bulevirtide for approximately 48 weeks and switch to receive tobevibart + elebsiran for additional 192 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ages 18 to 70 years at screening
- Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
- Noncirrhotic or compensated cirrhotic liver disease at screening
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 10 IU/ml at screening, currently on locally approved NRTI therapy
Key exclusion criteria (9 listed)
- Serum ALT ≥ 5 × ULN
- Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
- History of significant liver disease from non-HBV or non-HDV etiology
- History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
- History of anaphylaxis
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 |
|---|---|---|
| TobevibartAlso: VIR-3434Tobevibart administered by subcutaneous injection | Drug | Arm 1, Arm 2 |
| ElebsiranAlso: VIR-2218Elebsiran administered by subcutaneous injection | Drug | Arm 1, Arm 2 |
| BulevirtideAlso: HepcludexBulevirtide administered by subcutaneous injection | Drug | Arm 2 |
Primary outcome
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48
Time frame: Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment
Time frame: 24 Weeks after End of Treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48
Time frame: Week 48
5 secondary outcomes
Change from baseline in HDV RNA at Week 48
Time frame: Week 48
Change from baseline in ALT at Week 48
Time frame: Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 96, Week 120, Week 144, Week 192 and Week 240
Time frame: Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in HDV RNA at Week 96, Week 120, Week 144, Week 192 and Week 240
Time frame: Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 96, Week 120, Week 144, Week 192 and Week 240
Time frame: Week 96 to Week 120, Week 144, Week 192 and Week 240
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 41586499Noack J, Anglero-Rodriguez Y, Gall J, Zhou J, LeBlanc S, Liebow A, Bakardjiev A, Hebner CM, Purcell LA, Jadhav V, Corti D, Lempp FA. Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0112725. doi: 10.1128/aac.01127-25. Epub 2026 Jan 26.
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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.
31 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tobevibart, Elebsiran and Bulevirtide in people with Viral Hepatitis, run by Vir Biotechnology, Inc. at 31 sites in 11 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Pakistan, United Kingdom, Belgium, Bulgaria and 6 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. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48 (time frame: Week 48). The study lists 3 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 NCT07142811, 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 16 Jan 2026.