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This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | 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 | Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS | Frequency and severity of TEAEs and serious AEs | Weeks 24, 48, 96, and 120, if applicable |
| Percentage of participants that achieve that achieve virologic response and ALT normalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 247 Garden Grove | Garden Grove | California | 92840 | United States | ||
| 242 Huntington Beach |
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| Brelovitug 900 mg |
| Drug |
Route of administration- Subcutaneous Injection |
|
| Delayed Treatment with Brelovitug 300mg | Drug | Route of administration- Subcutaneous Injection |
|
Change from baseline in HDV RNA and ALT normalization |
| Weeks 24, 48, 96, and 120, if applicable |
| Percentage of participants with a composite endpoint by treatment regimen | Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug | Weeks 24, 48, 96, and 120, if applicable |
| Percentage of participants with HDV associated liver disease progression | Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs. | Weeks 24, 48, 96, and 120, if applicable |
| Huntington Beach |
| California |
| 92647 |
| United States |
| 252 Long Beach | Long Beach | California | 90805 | United States |
| 244 Los Angeles | Los Angeles | California | 90033 | United States |
| 250 Miami | Miami | Florida | 33166 | United States |
| 251, Illinois | Chicago | Illinois | 60612 | United States |
| 248 Lowa | Cities in Iowa | Iowa | 52242 | United States |
| 254 Baltimore | Baltimore | Maryland | 21287 | United States |
| 241, Massachusetts | Boston | Massachusetts | 02114 | United States |
| 245 New York | New York | New York | 10007 | United States |
| 256 New York | New York | New York | 10065 | United States |
| 253 New York | New York | New York | 10075 | United States |
| 255 New York | New York | New York | 10075 | United States |
| 257 Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| 249 San Antonio | San Antonio | Texas | 78215 | United States |
| 102 Melbourne | Melbourne | Victoria | Australia |
| 101 Camperdown | Camperdown | Australia |
| 104 Liverpool | Liverpool | Australia |
| 703 Sliven | Sliven | Silven | 8800 | Bulgaria |
| 705 Plovdiv | Plovdiv | Bulgaria |
| 702 Bulgaria | Sofia | Bulgaria |
| 706 Sofia | Sofia | Bulgaria |
| 704 Stara Zagora | Stara Zagora | Bulgaria |
| 233 Calgary | Calgary | Calgary | Canada |
| 234 Alberta | Edmonton | Edmonton | T6G 2G5 | Canada |
| 231 Toronto | Toronto | Ontario | Canada |
| 235 Montreal | Montreal | Quebec | Canada |
| 181 Tbilisi | Tbilisi | 0105 | Georgia |
| 183 Tbilisi | Tbilisi | 0105 | Georgia |
| 182 Tbilisi | Tbilisi | Georgia |
| 212 Haifa | Haifa | Haifa District | Israel |
| 211 Israel | Beersheba | Israel |
| 901 Chisinau | Chisinau | Moldova |
| 001 Auckland | Auckland | New Zealand |
| 221 Karachi City | Karachi | Karachi | Pakistan |
| 291 Belgrade | Belgrade | Belgrade | Serbia |
| 191 Istanbul | Istanbul | Istanbul | Turkey (Türkiye) |
| 110 Kyiv | Kyiv | 01001 | Ukraine |
| 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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