Viral HepatitisPhase 3NCT07128550
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
A Phase 3 study testing Tobevibart, Elebsiran and Bulevirtide in people with Viral Hepatitis, run by Vir Biotechnology, Inc. at 38 sites in 7 countries.
Trial summary
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide 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
- 150 participants
- Where
- 38 sitesin 7 countries
- Study dates
- 30 Jul 2025to Jul 2031
- Phase
- Phase 3
- 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
- HDV RNA ≥ 500 IU/mL at screening
- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- 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
- 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.
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
France11 sites
Investigative Site
Bobigny, 93009
Investigative Site
Clichy, 92110
Investigative Site
Créteil, 94000
Investigative Site
Le Chesnay, 78150
Investigative Site
Limoges, 87000
Investigative Site
Lyon, 69004
Investigative Site
Montpellier, 34295
Investigative Site
Pessac, 33604
Investigative Site
Rennes, 35033
Investigative Site
Toulouse, 31059
Investigative Site
Villejuif, 94804
Italy7 sites
Investigative Site
Bergamo, 24127
Investigative Site
Foggia, 71122
Investigative Site
Milan, 20089
Investigative Site
Milan, 20122
Investigative Site
Pisa, 56124
Investigative Site
Torino, 10122
Investigative Site
Torino, 10126
Spain5 sites
Investigative Site
Barcelona, 08035
Investigative Site
Barcelona, 08036
Investigative Site
Madrid, 28007
Investigative Site
Madrid, 28046
Investigative Site
Santander, 39008
United Kingdom5 sites
Investigative Site
London, E1 1FR
Investigative Site
London, SE5 9NU
Investigative Site
London, W2 1NY
Investigative Site
Manchester, M8 5RB
Investigative Site
Nottingham, NG7 2UH
Germany4 sites
Investigative Site
Berlin, 13353
Investigative Site
Essen, 45147
Investigative Site
Frankfurt am Main, 60590
Investigative Site
Hanover, 30625
Romania4 sites
Investigative Site
Bucharest, 021105
Investigative Site
Bucharest, 022328
Investigative Site
Bucharest, 030303
Investigative Site
Craiova, 200073
Austria2 sites
Investigative Site
Innsbruck, 6020
Investigative Site
Vienna, 1090
About this study
Official title: A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
- 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 24 weeks and switch to receive tobevibart + elebsiran for additional 216 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 24
Measured: Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.
Measured: 24 Weeks after End of Treatment
Secondary outcomes (3)
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Measured: Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240
Measured: Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Measured: Week 24, Week 48, Week 96, 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 posted19 Aug 2025
- Study start30 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2031 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT07128550
- Sponsor's protocol ID
- VIR-CHDV-V205
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2025
- Last updated
- 13 Jul 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)
- ClinicalTrials.gov ID
- NCT07128550
- Acronym / sponsor ID
- VIR-CHDV-V205
- 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 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 19 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.
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
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 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ages 18 to 70 years at screening
- HDV RNA ≥ 500 IU/mL at screening
- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- 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 (8 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 24
Time frame: Week 24
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
3 secondary outcomes
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Time frame: Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240
Time frame: Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Time frame: Week 24, Week 48, Week 96, 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 13 Jul 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.
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobevibart, Elebsiran and Bulevirtide in people with Viral Hepatitis, run by Vir Biotechnology, Inc. at 38 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 8 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in France, Italy, Spain, United Kingdom, Germany 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 (time frame: Week 24). 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 NCT07128550, 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 13 Jul 2026.