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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522105-38-00 | EU Trial (CTIS) Number |
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This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.
The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 to one of the following treatment arms:
Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.
Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brelovitug 300 mg | Drug | Route of administration- Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm | 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]) | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events (TEAEs) | An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event. | Up to 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Note - Other protocol-defined Inclusion/Exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States | ||
| Kaiser Permanente Medical Center |
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| Brelovitug 900 mg | Drug | Route of administration- Subcutaneous Injection |
|
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| Delayed Treatment with Brelovitug 300mg | Drug | Route of administration- Subcutaneous Injection |
|
|
| Percentage of participants who discontinue treatment due to an adverse event (AE) |
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event. |
| Up to 96 weeks |
| Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND | Up to 96 Weeks |
| Percentage of participants with HDV RNA <LLOQ | Up to 96 Weeks |
| Percentage of participants with HDV RNA <LLOQ, TND | Up to 96 Weeks |
| Percentage of participants with ALT normalization | ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN | Up to 96 Weeks |
| Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or <LLOQ, TND | The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND. | Up to 96 Weeks |
| Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ | The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \ | Up to 96 Weeks |
| Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND | The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \ | Up to 96 Weeks |
| Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up. | Post-Treatment Weeks 24 and 48 |
| Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) | Up to 96 Weeks |
| Change from baseline in APRI (AST-to-platelet ratio index) | Up to 96 Weeks |
| Change from baseline in CTP score in participants with cirrhosis | Up to 96 Weeks |
| Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis | Up to 96 Weeks |
| Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease. | Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC). | Up to 96 Weeks |
| Sacramento |
| California |
| 95661 |
| United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| Alliance Clinical, Las Vegas | Las Vegas | Nevada | 89019 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Prime Clinical Research Inc | Mansfield | Texas | 76063 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Erasme Hospital | Brussels | Belgium |
| University Hospital Antwerp (UZA) | Edegem | Belgium |
| University Hospital Center Sart-Tilman | Liège | Belgium |
| Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda | Sofia | 1407 | Bulgaria |
| Hospital Service LTD | Kutaisi | 4608 | Georgia |
| Diakori LLC | Tbilisi | 0159 | Georgia |
| JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi | 0159 | Georgia |
| LTD Academician Vakhtang Bochorishvili Clinic | Tbilisi | 0160 | Georgia |
| Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases | Budapest | H-1097 | Hungary |
| Fejer County St. Gyorgy University Teaching Hospital | Székesfehérvár | H-8000 | Hungary |
| Soroka University Medical Center | Beersheba | 8410101 | Israel |
| HaEmek Medical Center | Haifa | 3296043 | Israel |
| Aga Khan University & Hospital | Karachi | Karachi | 74800 | Pakistan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807377 | Taiwan |
| E-Da Hospital | Kaohsiung City | 82445 | Taiwan |
| National Taiwan University Hospital | Taipei | 100225 | Taiwan |
| Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life" | Poltava | 36000 | Ukraine |
| Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council | Rivne | 33018 | Ukraine |
| Research Institute of Virology of the Republic of Uzbekistan | Tashkent | 100194 | Uzbekistan |
| 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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