Clinical trial NCT06245291: Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection
Official title: A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Lead sponsor: Arbutus Biopharma Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria:

* Male or female between the ages of 18-65
* Willing and able to provide informed consent
* Willing to follow protocol-specified contraception requirement

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects
timeFrame: Up to 96 weeks
Secondary outcomes:
measure: To determine the effect of imdusiran and durvalumab on HBsAg
timeFrame: Up to 96 Weeks
measure: To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time
timeFrame: Up to 48 Weeks
measure: To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Infectious Diseases, AIDS and Clinical Immunology Research Center
city: Tbilisi
country: Georgia
facility: LLC "Neolab"
city: Hong Kong
country: Hong Kong
facility: Prince Of Wales Hospital - The Chinese University Of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Gdańsk
country: Poland
facility: Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska
city: Mysłowice
country: Poland
facility: ID Clinic Arkadiusz Pisula
city: Wrocław
country: Poland
facility: Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska
city: Bucharest
country: Romania
facility: Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Chia-Yi City
country: Taiwan
facility: Chia-yi Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: The Hiv Netherlands Australia Thailand Research Collaboration
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital
city: London
country: United Kingdom
facility: Imperial College Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
References: