This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Tobevibart administered by subcutaneous injection
Elebsiran administered by subcutaneous injection
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
Time frame: Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Time frame: Up to 12 weeks
HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
Time frame: Up to 48 weeks
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Investigative Site
Chandler, Arizona, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
Redwood City, California, United States
Investigative Site
San Francisco, California, United States
Investigative Site
DeLand, Florida, United States
Investigative Site
Chicago, Illinois, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Hillsborough, New Jersey, United States
Investigative Site
New York, New York, United States
Investigative Site
New York, New York, United States
...and 29 more locations