This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection. Eligible participants will be randomized 1:1:1 to one of three groups: libevitug 20 mg/kg group , libevitug 10 mg/kg (N=50) group, or a control/delayed treatment group (N=50). The treatment groups will receive intravenous libevitug every 2 weeks for 96 weeks, while the control group will be observed for the first 48 weeks and then receive libevitug 20 mg/kg Q2W for 48 weeks starting from Week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Route of administration: intravenous infusion
Route of administration: intravenous infusion
Route of administration: intravenous infusion
Proportion of participants with HDV RNA below LLOQ with TND or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period
Proportion of participants with HDV RNA below Lower Limit of Quantification (LLOQ) with target not detected (TND) or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period
Time frame: Week 48
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization
Time frame: up to week 96
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline
Time frame: up to week 96
Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ
Time frame: up to week 96
Proportion of participants with ALT normalization
Time frame: up to week 96
Change from baseline in liver stiffness measurement (LSM)
Time frame: up to week 96
Change from baseline in plasma HDV RNA levels at different time points
Time frame: up to week 96
Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points
Time frame: up to week 96
Change from baseline in Child-Pugh score at different time points during the treatment period, extended treatment period and follow-up period. (A higher Child-Pugh score indicates poorer liver function, more severe disease, and a worse prognosis)
Time frame: up to week 96
Liver related clinical events
Time frame: up to week 120
Percentage of participants with treatment-emergent adverse events (TEAEs)
Time frame: up to week 120
Ctrough,ss
Steady-state trough concentration of libevitug
Time frame: up to week 96
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