Chronic Hepatitis D Infection
Conditions
Keywords
Hepatitis Delta Virus (HDV), Viral hepatitis
Brief summary
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.
Interventions
DRUGLibevitug 20 mg/kg
Route of administration: intravenous infusion
DRUGLibevitug 10 mg/kg
Route of administration: intravenous infusion
OTHERDelayed treatment with libevitug
Route of administration: intravenous infusion
Sponsors
Huahui Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Willing to sign written informed consent; * Chronic HDV history with at least 6 months; * HDV RNA ≥500 IU/mL at screening; * ALT \>1ULN and \<10×ULN; * Able to communicate well and comply with protocol.
Exclusion criteria
* Concomitant decompensated cirrhosis; * Previous or current HCC or suspicion for HCC; * Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV; * Participants with active hepatitis C infection, or HIV infection; * Alcohol abuse or drug addiction within 1 year; * Participants have participated in other clinical trial within 1 month; * Pregnant, lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 48 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ctrough,ss | up to week 96 | Steady-state trough concentration of libevitug |
| Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization | up to week 96 | — |
| Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline | up to week 96 | — |
| Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ | up to week 96 | — |
| Proportion of participants with ALT normalization | up to week 96 | — |
| Change from baseline in liver stiffness measurement (LSM) | up to week 96 | — |
| Change from baseline in plasma HDV RNA levels at different time points | up to week 96 | — |
| Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points | 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) | up to week 96 | — |
| Percentage of participants with treatment-emergent adverse events (TEAEs) | up to week 120 | — |
| Liver related clinical events | up to week 120 | — |
Countries
China, Pakistan, United States
Contacts
CONTACTJiaying Wen PM
Outcome results
None listed