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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
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).
Age
18 - 69 years
Sex
ALL
Healthy Volunteers
No
Investigative Site
Sofia, Bulgaria
Investigative Site
Sofia, Bulgaria
Investigative Site
Stara Zagora, Bulgaria
Investigative Site
Clichy, France
Investigative Site
Pessac, France
Investigative Site
Rennes, France
Investigative Site
Toulouse, France
Investigative Site
Frankfurt, Germany
Investigative Site
Hanover, Germany
Investigative Site
Tübingen, Germany
Start Date
September 17, 2022
Primary Completion Date
August 1, 2029
Completion Date
August 1, 2029
Last Updated
October 14, 2025
95
ACTUAL participants
VIR-2218
DRUG
VIR-3434
DRUG
NRTI
DRUG
Lead Sponsor
Vir Biotechnology, Inc.
NCT04166266
NCT06603311
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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