SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection
Hepatitis D, Chronic
About this trial
This is an interventional treatment trial for Hepatitis D, Chronic focused on measuring HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus
Eligibility Criteria
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.
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative SiteRecruiting
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative Site
- Investigative SiteRecruiting
- Investigative Site
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Cohort 1a (VIR-2218)
Cohort 1b (VIR-3434)
Cohort 2a (VIR-2218)
Cohort 2b1 (VIR-3434)
Cohort 2b2 (VIR-3434)
Cohort 2c (VIR-2218 + VIR-3434)
Cohort 3 (VIR-3434)
Cohort 4 (NRTI)
Participants will receive multiple doses of VIR-2218 for up to 96 weeks total
Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.
Participants will receive multiple doses of VIR-2218 for 96 weeks.
Participants will receive multiple doses of VIR-3434 for 96 weeks.
Participants will receive multiple doses of VIR-3434 for 96 weeks.
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 96 weeks total
Participants will receive multiple doses of VIR-3434 for 48 or 96 weeks.
Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.