Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07298330 | A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) | PHASE3 | RECRUITING | 80 | — | — | Jan 14, 2026 | Jan 1, 2029 | Mar 2, 2026 | 27 | United States, Belgium +8 |
| NCT07200908 | A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) | PHASE3 | RECRUITING | 172 | — | — | Aug 27, 2025 | Sep 30, 2029 | Mar 27, 2026 | 44 | Austria, Czechia +8 |
| NCT06907290 | A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection | PHASE2 | ACTIVE NOT_RECRUITING | 150 | — | — | Mar 25, 2025 | Sep 1, 2029 | Mar 2, 2026 | 38 | United States, Australia +10 |
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (\< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])
The composite endpoint is defined as virologic response (undetectable HDV RNA, \< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])
Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization
| Arm | Type | Description |
|---|---|---|
| Brelovitug 300 mg | EXPERIMENTAL | Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks |
| Brelovitug 900 mg | EXPERIMENTAL | Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks |
| Delayed treatment with brelovitug 300 mg | ACTIVE_COMPARATOR | Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks |
| Brelovitug | EXPERIMENTAL | Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks |
| Bulevirtide for 48 weeks followed by brelovitug for 48 weeks | ACTIVE_COMPARATOR | Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks. |
| Brelovitug 300mg | EXPERIMENTAL | Dose - brelovitug 300 mg Frequency- once weekly |
| Brelovitug 900mg | EXPERIMENTAL | Dose - brelovitug 900 mg Frequency- once every 4 weeks |
| Delayed Treatment with brelovitug 300mg | ACTIVE_COMPARATOR | Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly |
| Name | Type | Description |
|---|---|---|
| Brelovitug 300 mg | DRUG | Route of administration- Subcutaneous Injection |
| Brelovitug 900 mg | DRUG | Route of administration- Subcutaneous Injection |
| Delayed Treatment with Brelovitug 300mg | DRUG | Route of administration- Subcutaneous Injection |
| Bulevirtide 2 mg and Brelovitug - 300 mg | DRUG | Route of Administration- Subcutaneous Injection |
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV nucleos(t)ide therapy. Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to com...