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

Phase 2Active Not RecruitingNCT05461170

Vir Biotechnology, Inc.95 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis D, Chronic

Interventions

VIR-2218DRUG

VIR-2218 given by subcutaneous injection

VIR-3434DRUG

VIR-3434 given by subcutaneous injection

NRTIDRUG

NRTI given orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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 * 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. * Anti-HBs \>10 mIU/mL at screening

Locations (20)

Investigative Site

Sofia, Bulgaria

Investigative Site

Sofia, Bulgaria

Outcomes

Primary Outcomes

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

Time frame: Up to 24 Weeks

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

Time frame: Up to 118 Weeks

Secondary Outcomes

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, and Week 192.

Time frame: Up to 192 Weeks

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, and Week 192.

Time frame: Up to 192 Weeks

Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.

Time frame: Up to 192 Weeks

Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.

Time frame: Up to 192 Weeks

Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.

Time frame: Up to 192 Weeks

Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.

Time frame: Up to 192 Weeks

Data from ClinicalTrials.gov

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