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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Libevitug 20 mg/kg | Experimental | Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks |
|
| Libevitug 10 mg/kg | Experimental | Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks |
|
| Control group/delayed treatment with libevitug 20 mg/kg | Active Comparator | Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Libevitug 20 mg/kg | Drug | Route of administration: intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HDV and HBV genotyping | baseline | |
| Change from baseline in quality of life assessed with questionnaire (Hepatitis B quality of life instrument (HBQoL) Version 1.0 and Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) version 4.0 ) at all postbaseline assessments |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaying Wen PM | Contact | +86 13552466248 | wenjiaying@hhhbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130033 | China |
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| Libevitug 10 mg/kg |
| Drug |
Route of administration: intravenous infusion |
|
| Delayed treatment with libevitug | Other | Route of administration: intravenous infusion |
|
| 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 |
| Liver related clinical events | up to week 120 |
| Percentage of participants with treatment-emergent adverse events (TEAEs) | up to week 120 |
| Ctrough,ss | Steady-state trough concentration of libevitug | up to week 96 |
| up to week 120 |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000096182 | Treatment Delay |
| ID | Term |
|---|---|
| D061665 | Time-to-Treatment |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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