NCT05461170

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	VIR-2218	VIR-2218 given by subcutaneous injection
DRUG	VIR-3434	VIR-3434 given by subcutaneous injection
DRUG	NRTI	NRTI given orally.

Timeline

• Start date: 2022-09-17
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2022-07-18
• Last updated: 2025-10-14

Locations

20 sites across 9 countries: Bulgaria, France, Germany, Italy, Moldova, Netherlands, New Zealand, Romania, United Kingdom

Regulatory

• FDA-regulated drug study