This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Tobevibart administered by subcutaneous injection
Elebsiran administered by subcutaneous injection
Bulevirtide administered by subcutaneous injection
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24
Time frame: Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.
Time frame: 24 Weeks after End of Treatment
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Time frame: Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240
Time frame: Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Time frame: Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigative Site
Innsbruck, Austria
Investigative Site
Vienna, Austria
Investigative Site
Bobigny, France
Investigative Site
Clichy, France
Investigative Site
Créteil, France
Investigative Site
Le Chesnay, France
Investigative Site
Limoges, France
Investigative Site
Lyon, France
Investigative Site
Montpellier, France
Investigative Site
Pessac, France
...and 28 more locations