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

Sponsor

Vir Biotechnology, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05461170

Collaborator

(none)

Enrollment

Location

Arms

51.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D, Chronic	Drug: VIR-2218 Drug: VIR-3434	Phase 2

Detailed Description

Participants may be enrolled into Cohorts 1a, 1b, 2, 3, 4 in a non-randomized manner.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1a (VIR-2218) Participants will receive multiple doses of VIR-2218 for up to 88 weeks total.	Drug: VIR-2218 VIR-2218 given by subcutaneous injection
Experimental: Cohort 1b (VIR-3434) Participants will receive multiple doses of VIR-3434 for up to 88 weeks total.	Drug: VIR-3434 VIR-3434 given by subcutaneous injection
Experimental: Cohort 2 (VIR-2218 + VIR-3434) Participants with specific inclusion criteria will receive multiple doses of VIR-2218 + VIR-3434 for up to 88 weeks total.	Drug: VIR-2218 VIR-2218 given by subcutaneous injection Drug: VIR-3434 VIR-3434 given by subcutaneous injection
Experimental: Cohort 3 (VIR-2218 + VIR-3434) Participants with specific inclusion criteria will receive multiple doses of VIR-2218 + VIR-3434 for up to 88 weeks total.	Drug: VIR-2218 VIR-2218 given by subcutaneous injection Drug: VIR-3434 VIR-3434 given by subcutaneous injection
Experimental: Cohort 4 (VIR-2218 + VIR-3434) Participants with specific inclusion criteria will receive multiple doses of VIR-2218 + VIR-3434 for up to 88 weeks total.	Drug: VIR-2218 VIR-2218 given by subcutaneous injection Drug: VIR-3434 VIR-3434 given by subcutaneous injection

Outcome Measures

Primary Outcome Measures

Proportion of participants achieving either a ≥ 2log10 decrease in HDV RNA compared to baseline or HDV RNA < Limit of Quantification with normal ALT at Week 24. [Up to 24 Weeks]
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Up to 102 Weeks]

Secondary Outcome Measures

Number of participants achieving either a ≥ 2log10 decrease in HDV RNA compared to baseline or HDV RNA < Limit of Quantification with normal ALT at end of Induction Period. [Up to 48 Weeks]
Number of participants in the Maintenance Period with sustained ≥ 2 log10 decrease in plasma HDV RNA or plasma HDV RNA < LOQ and normal ALT. [Up to 96 Weeks]
Change of HDV RNA from baseline [Up to 96 Weeks]
Incidence of anti-drug antibodies to VIR-3434 [Up to 96 Weeks]
Titers of anti-drug antibodies to VIR-3434 [Up to 96 Weeks]
Change from Baseline to Liver Fibrosis [Up to 96 Weeks]
Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.
Change in Model for End Stage Liver Disease (MELD) Score from baseline [Up to 96 Weeks]
MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.
Change from baseline Child-Pugh-Turcotte (CPT) Class [Up to 96 Weeks.]
Class A-C. Class A (mild hepatic impairment), B (moderate hepatic impairment) and C (severe hepatic impairment)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female ages 18 -< 70 years
Chronic HDV infection for >/= 6 months
On NRTI therapy for >/= 2 months at the time of screening

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.