SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
- Registration Number
- NCT05461170
- Lead Sponsor
- Vir Biotechnology, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1b (VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-3434 for up to 96 weeks total. Cohort 4 (NRTI) NRTI Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3. Cohort 5 (VIR-2218) VIR-2218 Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c. Cohort 1a (VIR-2218) VIR-2218 Participants will receive multiple doses of VIR-2218 for up to 96 weeks total. Cohort 2b1 (VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-3434 for up to 192 weeks. Cohort 2b2 (VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-3434 for up to 192 weeks. Cohort 3 (VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-3434 for up to 192 weeks. Cohort 2a (VIR-2218) VIR-2218 Participants will receive multiple doses of VIR-2218 for up to 192 weeks. Cohort 2c (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 192 weeks. Cohort 2c (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 192 weeks.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 Up to 192 Weeks MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.
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 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 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 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 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 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 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 Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, and Week 192 Up to 192 Weeks. Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.
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
Trial Locations
- Locations (1)
Investigative Site
🇬🇧Manchester, United Kingdom