Hepatitis D, ChronicPhase 2NCT05461170
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
A Phase 2 study testing VIR-2218, VIR-3434 and NRTI in people with Hepatitis D, Chronic, run by Vir Biotechnology, Inc. at 20 sites in 9 countries.
Trial summary
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatitis D, Chronic
- What is being tested?
- VIR-2218, VIR-3434 and NRTI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 17 Sep 2022to May 2032
- 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 69 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 for at least 12 weeks prior to day 1
- ALT>ULN and < 5x ULN
- Non-cirrhotic and CPT-A cirrhotic
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
Show all 9Show fewer
- History or evidence of alcohol or drug abuse
- Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.
- Anti-HBs >10 mIU/mL at screening
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
France4 sites
Investigative Site
Clichy, 92110
Investigative Site
Pessac, 33600
Investigative Site
Rennes, 35000
Investigative Site
Toulouse, 31000
United Kingdom4 sites
Investigative Site
Birmingham, B15 2TT
Investigative Site
London, E1 1RF
Investigative Site
London, SE5 9RS
Investigative Site
Manchester, M8 5RB
Bulgaria3 sites
Investigative Site
Sofia, 1407
Investigative Site
Sofia, 1431
Investigative Site
Stara Zagora, 6003
Germany3 sites
Investigative Site
Frankfurt, 60596
Investigative Site
Hanover, 30625
Investigative Site
Tübingen, 72076
About this study
Official title: A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Read the detailed description
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).
- Conditions
- Hepatitis D, Chronic
- Being tested
- VIR-2218, VIR-3434, NRTI
- Keywords
- HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis Delta Virus
- Medical subject headings
- Hepatitis D, Chronic, Hepatitis, Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-2218Drug
Also called Elebsiran
VIR-2218 given by subcutaneous injection
VIR-3434Drug
Also called Tobevibart
VIR-3434 given by subcutaneous injection
NRTIDrug
NRTI given orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a (VIR-2218) | Experimental | Participants will receive multiple doses of VIR-2218 for up to 96 weeks total. Receives: Drug: VIR-2218 |
| Cohort 1b (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 96 weeks total. Receives: Drug: VIR-3434 |
| Cohort 2a (VIR-2218) | Experimental | Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c. Receives: Drug: VIR-2218 |
| Cohort 2b1 (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. Receives: Drug: VIR-3434 |
| Cohort 2b2 (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. Receives: Drug: VIR-3434 |
| Cohort 2c (VIR-2218 + VIR-3434) | Experimental | Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks. Receives: Drug: VIR-2218; Drug: VIR-3434 |
| Cohort 3 (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c. Receives: Drug: VIR-3434 |
| Cohort 4 (NRTI) | Placebo comparator | Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3. Receives: Drug: NRTI |
| Cohort 5 (VIR-2218) | Experimental | Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c. Receives: Drug: VIR-2218 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24
Measured: Up to 24 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Up to 360 Weeks
Secondary outcomes (10)
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 336 (for cohorts with VIR3434)
Measured: Up to 336 Weeks
Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.
Measured: Up to 336 Weeks.
Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.
Measured: Up to 336 Weeks
Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Measured: Up to 336 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start17 Sep 2022
- Primary completionNov 2031 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis D, 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 95 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
- NCT05461170
- Sponsor's protocol ID
- VIR-CHDV-V201
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 41586499Asselah T, Chattergoon MA, Jucov A, Streinu-Cercel A, Lampertico P, Wedemeyer H, Kennedy PT, Gane EJ, Bullard BL, Chow S, Santos D, Camus G, Lu Y, Pilowa C, Hwang C, Correll T, Agarwal K; SOLSTICE Trial Investigators. A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D. N Engl J Med. 2026 Jan 22;394(4):343-353. doi: 10.1056/NEJMoa2508827. Epub 2025 Nov 9.
PubMed 41211943
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)
- ClinicalTrials.gov ID
- NCT05461170
- Acronym / sponsor ID
- VIR-CHDV-V201
- Conditions
- Hepatitis D, Chronic
- Keywords
- HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis Delta Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 18 Jul 2022 (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 phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Detailed description
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a (VIR-2218) | Experimental | Drug: VIR-2218Participants will receive multiple doses of VIR-2218 for up to 96 weeks total. |
| Cohort 1b (VIR-3434) | Experimental | Drug: VIR-3434Participants will receive multiple doses of VIR-3434 for up to 96 weeks total. |
| Cohort 2a (VIR-2218) | Experimental | Drug: VIR-2218Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c. |
| Cohort 2b1 (VIR-3434) | Experimental | Drug: VIR-3434Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. |
| Cohort 2b2 (VIR-3434) | Experimental | Drug: VIR-3434Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. |
| Cohort 2c (VIR-2218 + VIR-3434) | Experimental | Drug: VIR-2218, Drug: VIR-3434Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks. |
| Cohort 3 (VIR-3434) | Experimental | Drug: VIR-3434Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c. |
| Cohort 4 (NRTI) | Placebo comparator | Drug: NRTIParticipants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3. |
| Cohort 5 (VIR-2218) | Experimental | Drug: VIR-2218Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c. |
Who may qualify
- Ages
- 18 to 69 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 for at least 12 weeks prior to day 1
- ALT>ULN and < 5x ULN
- Non-cirrhotic and CPT-A cirrhotic
Key exclusion criteria (9 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 |
|---|---|---|
| VIR-2218Also: ElebsiranVIR-2218 given by subcutaneous injection | Drug | Cohort 1a (VIR-2218), Cohort 2a (VIR-2218), Cohort 2c (VIR-2218 + VIR-3434), Cohort 5 (VIR-2218) |
| VIR-3434Also: TobevibartVIR-3434 given by subcutaneous injection | Drug | Cohort 1b (VIR-3434), Cohort 2b1 (VIR-3434), Cohort 2b2 (VIR-3434), Cohort 2c (VIR-2218 + VIR-3434), Cohort 3 (VIR-3434) |
| NRTINRTI given orally. | Drug | Cohort 4 (NRTI) |
Primary outcome
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24
Time frame: Up to 24 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 360 Weeks
10 secondary outcomes
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 336 (for cohorts with VIR3434)
Time frame: Up to 336 Weeks
Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks.
Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 Weeks
Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.
Time frame: Up to 336 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 26 Jun 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.
- Derived from this study: PubMed 41211943Asselah T, Chattergoon MA, Jucov A, Streinu-Cercel A, Lampertico P, Wedemeyer H, Kennedy PT, Gane EJ, Bullard BL, Chow S, Santos D, Camus G, Lu Y, Pilowa C, Hwang C, Correll T, Agarwal K; SOLSTICE Trial Investigators. A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D. N Engl J Med. 2026 Jan 22;394(4):343-353. doi: 10.1056/NEJMoa2508827. Epub 2025 Nov 9.
- Individual participant dataSharing planned: No
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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.
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VIR-2218, VIR-3434 and NRTI in people with Hepatitis D, Chronic, run by Vir Biotechnology, Inc. at 20 sites in 9 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 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, United Kingdom, Bulgaria, Germany, Italy and 4 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 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?
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24 (time frame: Up to 24 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 NCT05461170, which also lists 2 linked publications.
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 26 Jun 2026.