Clinical trial NCT05461170: SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatitis D, Chronic
Keywords: HDV
Hepatitis D Virus
Hepatitis
Chronic Hepatitis D Virus
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5.

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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 Weeks
measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Up to 118 Weeks
Secondary outcomes:
measure: 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.
timeFrame: Up to 192 Weeks
measure: 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.
timeFrame: Up to 192 Weeks
measure: 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.
timeFrame: Up to 192 Weeks
measure: 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.
timeFrame: Up to 192 Weeks
measure: Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
timeFrame: Up to 192 Weeks
measure: Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
timeFrame: Up to 192 Weeks
measure: Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 192 (for cohorts with VIR3434)
timeFrame: Up to 192 Weeks
measure: Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, and Week 192
timeFrame: Up to 192 Weeks.
measure: Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, and Week 192
timeFrame: Up to 192 Weeks
measure: Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192
timeFrame: Up to 192 Weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Investigative Site
city: Sofia
country: Bulgaria
facility: Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Investigative Site
city: Clichy
country: France
facility: Investigative Site
city: Pessac
country: France
facility: Investigative Site
city: Rennes
country: France
facility: Investigative Site
city: Toulouse
country: France
facility: Investigative Site
city: Frankfurt
country: Germany
facility: Investigative Site
city: Hannover
country: Germany
facility: Investigative Site
city: Tübingen
country: Germany
facility: Investigative Site
city: Milano
country: Italy
facility: Investigative Site
city: Pisa
country: Italy
facility: Investigative Site
city: Chisinau
country: Moldova, Republic of
facility: Investigative Site
city: Rotterdam
country: Netherlands
facility: Investigative Site
city: Auckland
country: New Zealand
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Birmingham
country: United Kingdom
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
city: Manchester
country: United Kingdom
facility: Investigative Site
Study officials:
References: