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

Hepatitis D, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461170
• Other study ID #: VIR-CHDV-V201
• Status: Recruiting
• Phase: Phase 2
• Start date: September 17, 2022
• Est. completion date: August 2029

Study information

• Verified date: November 2023
• Source: Vir Biotechnology, Inc.
• Contact: Study Inquiry
• Phone: 415-654-5281
• Email: clinicaltrials[@]vir.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: August 2029
• Est. primary completion date: August 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• VIR-2218
VIR-2218 given by subcutaneous injection
• VIR-3434
VIR-3434 given by subcutaneous injection
• NRTI
NRTI given orally.

Locations

Country	Name	City	State
Bulgaria	Investigative Site	Sofia
Bulgaria	Investigative Site	Sofia
Bulgaria	Investigative Site	Stara Zagora
France	Investigative Site	Clichy
France	Investigative Site	Pessac
France	Investigative Site	Rennes
France	Investigative Site	Toulouse
Germany	Investigative Site	Frankfurt
Germany	Investigative Site	Hannover
Germany	Investigative Site	Tübingen
Italy	Investigative Site	Milano
Italy	Investigative Site	Pisa
Moldova, Republic of	Investigative Site	Chisinau
Netherlands	Investigative Site	Rotterdam
New Zealand	Investigative Site	Auckland
Romania	Investigative Site	Bucharest
United Kingdom	Investigative Site	Birmingham
United Kingdom	Investigative Site	London
United Kingdom	Investigative Site	London
United Kingdom	Investigative Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vir Biotechnology, Inc.

Countries where clinical trial is conducted

Bulgaria,  France,  Germany,  Italy,  Moldova, Republic of,  Netherlands,  New Zealand,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)		Up to 118 Weeks
Secondary	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.		Up to 192 Weeks
Secondary	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.		Up to 192 Weeks
Secondary	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.		Up to 192 Weeks
Secondary	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.		Up to 192 Weeks
Secondary	Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.		Up to 192 Weeks
Secondary	Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.		Up to 192 Weeks
Secondary	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)		Up to 192 Weeks
Secondary	Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, and Week 192	Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.	Up to 192 Weeks.
Secondary	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	MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.	Up to 192 Weeks
Secondary	Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192		Up to 192 Weeks