SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
← catalyst calendarNCT05461170 · readout ≤ 1,928 d
Sponsored by Vir Biotechnology, Inc. (industry) · VIR — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
95actual
Sites
20
Countries
Bulgaria, France, Germany +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-09-17 | actual | When the study began enrolling |
| Primary completion | Nov 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2022-07-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hepatitis D, Chronic
Interventions
- Drug: VIR-2218 — also filed as Elebsiran
- Drug: VIR-3434 — also filed as Tobevibart
- Drug: NRTI
Primary outcomes
what the primary-completion date above is the date OFProportion 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
Publications
- PMID 41586499 — linked by the registry
- PMID 41211943 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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