Viral HepatitisPhase 3NCT06903338
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
A Phase 3 study testing Tobevibart and Elebsiran in people with Viral Hepatitis, run by Vir Biotechnology, Inc. at 39 sites in 10 countries.
Trial summary
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment. 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 and Elebsiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 39 sitesin 10 countries
- Study dates
- 12 Mar 2025to May 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
- Chronic HDV infection for >/= 6 months
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 20 IU/ml at screening, currently on locally approved NRTI therapy
- Serum ALT > ULN and < 5x ULN
- Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
Who cannot join
- 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
- History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
Trial locations and contacts
39 sites in 10 countries.
39 sites in 10 countries
United States13 sites
Investigative Site
Baltimore, Maryland, 21287
Investigative Site
Chandler, Arizona, 85224
Investigative Site
Chicago, Illinois, 60612
Investigative Site
DeLand, Florida, 32720
Investigative Site
Hillsborough, New Jersey, 08844
Investigative Site
Los Angeles, California, 90033
Investigative Site
Murray, Utah, 84107
Investigative Site
New York, New York, 10016
Investigative Site
New York, New York, 10021
Investigative Site
New York, New York, 10029
Investigative Site
Redwood City, California, 94063
Investigative Site
San Francisco, California, 94143
Investigative Site
Seattle, Washington, 98105
Canada6 sites
Investigative Site
Calgary, Alberta, T2N 4Z6
Investigative Site
Montreal, Quebec, H2L 4E9
Investigative Site
Montreal, H2X 1R9
Investigative Site
Ottawa, K1H8L6
Investigative Site
Québec, G1V 4G2
Investigative Site
Vancouver, V6Z 2C7
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
Georgia3 sites
Investigative Site
Tbilisi, 0102
Investigative Site
Tbilisi, 0114
Investigative Site
Tbilisi, 0159
Germany3 sites
Investigative Site
Frankfurt, 60590
Investigative Site
Hanover, 30625
Investigative Site
Heidelberg, 69120
Romania3 sites
Investigative Site
Bucharest, 021105
Investigative Site
Bucharest, 022328
Investigative Site
Bucharest, 030303
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 (ECLIPSE 1)
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
- Conditions
- Viral Hepatitis
- Being tested
- Tobevibart, Elebsiran
- Keywords
- HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus
- Medical subject headings
- Hepatitis, Hepatitis D, Hepatitis D, Chronic
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Tobevibart + Elebsiran) | Experimental | Participants will receive treatment with tobevibart + elebsiran for 240 weeks. Receives: Drug: Tobevibart; Drug: Elebsiran |
| Arm 2 (Tobevibart + Elebsiran) | Experimental | Participants will receive tobevibart + elebsiran after an observational period for 240 weeks. Receives: Drug: Tobevibart; Drug: Elebsiran |
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) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
Measured: Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Measured: Up to 12 weeks
Secondary outcomes (1)
HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start12 Mar 2025
- Primary completion30 Sep 2026
- Study completionMay 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
- 124 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
- NCT06903338
- Sponsor's protocol ID
- VIR-CHDV-V203
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2025
- Last updated
- 3 Nov 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 3 Nov 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 (ECLIPSE 1)
- ClinicalTrials.gov ID
- NCT06903338
- Acronym / sponsor ID
- VIR-CHDV-V203
- Conditions
- Viral Hepatitis
- Keywords
- HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- May 2031 (estimated)
- First posted
- 30 Mar 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 the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Tobevibart + Elebsiran) | Experimental | Drug: Tobevibart, Drug: ElebsiranParticipants will receive treatment with tobevibart + elebsiran for 240 weeks. |
| Arm 2 (Tobevibart + Elebsiran) | Experimental | Drug: Tobevibart, Drug: ElebsiranParticipants will receive tobevibart + elebsiran after an observational period for 240 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
- Chronic HDV infection for >/= 6 months
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 20 IU/ml at screening, currently on locally approved NRTI therapy
- Serum ALT > ULN and < 5x ULN
- Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
Key exclusion criteria (7 listed)
- 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
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 (Tobevibart + Elebsiran), Arm 2 (Tobevibart + Elebsiran) |
| ElebsiranAlso: VIR-2218Elebsiran administered by subcutaneous injection | Drug | Arm 1 (Tobevibart + Elebsiran), Arm 2 (Tobevibart + Elebsiran) |
Primary outcome
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
Time frame: Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Time frame: Up to 12 weeks
1 secondary outcome
HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
Time frame: Up to 48 weeks
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 3 Nov 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.
39 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobevibart and Elebsiran in people with Viral Hepatitis, run by Vir Biotechnology, Inc. at 39 sites in 10 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 7 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada, Pakistan, United Kingdom, Georgia and 5 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) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2 (time frame: Up to 48 weeks). 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 NCT06903338, 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 3 Nov 2026.