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Sponsor Decision
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This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints |
|
| Cohort B | Experimental | Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints |
|
| Cohort C | Experimental | Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imdusiran | Drug | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects | • Number of participants with treatment emergent adverse events (TEAEs), immune related adverse events (irAEs), with discontinuations due to adverse events (AEs) and irAEs, with abnormal laboratory tests results, abnormal Vital signs, abnormal physical exam findings and abnormal electrocardiogram (ECG) readings | Up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of imdusiran and durvalumab on HBsAg | • Change in HBsAg levels from baseline during treatment and follow-up | Up to 96 Weeks |
| To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi | 0160 | Georgia | |||
| LLC "Neolab" |
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| Durvalumab |
| Drug |
intravenous injection |
|
• Measurement of soluble immune marker levels in plasma at multiple timepoints |
| Up to 48 Weeks |
| To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48 | • Proportion of subjects at Week 48 who are HBeAg negative and meet protocol defined ALT, HBV DNA and HBsAg values | Up to Week 48 |
| Tbilisi |
| 0186 |
| Georgia |
| Prince Of Wales Hospital - The Chinese University Of Hong Kong | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska | Gdansk | Poland |
| ID Clinic Arkadiusz Pisula | Mysłowice | Poland |
| Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska | Wroclaw | Poland |
| Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase | Bucharest | Romania |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Chia-yi Christian Hospital | Chia-Yi City | Taiwan |
| Kaohsiung Medical University Chung-ho Memorial Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand |
| Siriraj Hospital | Bangkok | Thailand |
| The Hiv Netherlands Australia Thailand Research Collaboration | Bangkok | Thailand |
| Srinagarind Hospital | Khon Kaen | Thailand |
| Naresuan University Hospital | Phitsanulok | Thailand |
| Imperial College Hospital | London | United Kingdom |
| Royal London Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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