Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection
- Registration Number
- NCT06245291
- Lead Sponsor
- Arbutus Biopharma Corporation
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Male or female between the ages of 18-65
- Willing and able to provide informed consent
- Willing to follow protocol-specified contraception requirement
Key
- Have extensive fibrosis or cirrhosis of the liver
- Have or had liver cancer (hepatocellular carcinoma)
- Family history or personal history/current thyroid disease on or off replacement therapy
- Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
- Females who are breastfeeding, pregnant or who wish to become pregnant during the study
- Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Imdusiran Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints Cohort B Imdusiran Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints Cohort C Imdusiran Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints Cohort A Durvalumab Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints Cohort B Durvalumab Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints Cohort C Durvalumab Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects Up to 96 weeks • 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
- Secondary Outcome Measures
Name Time Method To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time Up to 48 Weeks • Measurement of soluble immune marker levels in plasma at multiple timepoints
To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48 Up to Week 48 • Proportion of subjects at Week 48 who are HBeAg negative and meet protocol defined ALT, HBV DNA and HBsAg values
To determine the effect of imdusiran and durvalumab on HBsAg Up to 96 Weeks • Change in HBsAg levels from baseline during treatment and follow-up
Trial Locations
- Locations (21)
Infectious Diseases, AIDS and Clinical Immunology Research Center
🇬🇪Tbilisi, Georgia
LLC "Neolab"
🇬🇪Tbilisi, 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
🇵🇱Wrocław, Poland
ID Clinic Arkadiusz Pisula
🇵🇱Mysłowice, 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
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