Clinical trial

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)

Name

VIR-CHDV-V201

Description

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

Trial arms

Trial start

2022-09-17

Estimated PCD

2029-08-01

Trial end

2029-08-01

Status

Recruiting

Phase

Early phase I

Treatment

VIR-2218

VIR-2218 given by subcutaneous injection

Arms:

Cohort 1a (VIR-2218), Cohort 2a (VIR-2218), Cohort 2c (VIR-2218 + VIR-3434), Cohort 5 (VIR-2218)

Other names:

Elebsiran

VIR-3434

VIR-3434 given by subcutaneous injection

Arms:

Cohort 1b (VIR-3434), Cohort 2b1 (VIR-3434), Cohort 2b2 (VIR-3434), Cohort 2c (VIR-2218 + VIR-3434), Cohort 3 (VIR-3434)

Other names:

Tobevibart

NRTI

NRTI given orally.

Arms:

Cohort 4 (NRTI)

Size

124

Primary endpoint

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

Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Up to 118 Weeks

Eligibility criteria

Inclusion Criteria: * 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 * Anti-HBs \>10 mIU/mL at screening if only adding a select set of EC * Non-cirrhotic and CPT-A cirrhotic Exclusion Criteria: * 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 * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 124, 'type': 'ESTIMATED'}}

Updated at

2024-04-24

1 organization

3 products

2 indications

Organization

Product

Indication

Indication

Product

Product