Trial · NCT05461170

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

NCT05461170, Phase 2, Active not recruiting, Vir Biotechnology, Inc.

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection. Trials, record NCT05461170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05461170

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
NCT number: NCT05461170
Status: Active not recruiting
Phases: Phase 2
Enrollment: 95 participants, actual
Lead sponsor: Vir Biotechnology, Inc.
Conditions: Hepatitis D, Chronic
Interventions: VIR-2218, VIR-3434, NRTI
First posted: 2022-07-18
Last updated: 2026-06-26

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Up to 24 Weeks
Primary	Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to 360 Weeks
Secondary	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.	Up to 336 Weeks
Secondary	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.	Up to 336 Weeks
Secondary	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.	Up to 336 Weeks
Secondary	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.	Up to 336 Weeks
Secondary	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.	Up to 336 Weeks
Secondary	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.	Up to 336 Weeks
Secondary	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)	Up to 336 Weeks
Secondary	Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.	Up to 336 Weeks.	Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
41211943	DERIVED	PubMed
41586499	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05461170

GET https://conductscience.org/api/trials/v1/NCT05461170/registered

API reference For AI assistants