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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06245291
Other study ID # AB-729-203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2024
Est. completion date July 2027

Study information

Verified date June 2024
Source Arbutus Biopharma Corporation
Contact Arbutus Biopharma
Phone 267-469-0914
Email clinicaltrials@arbutusbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2027
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Imdusiran
subcutaneous injection
Durvalumab
intravenous injection

Locations

Country Name City State
Georgia Infectious Diseases, AIDS and Clinical Immunology Research Center Tbilisi
Georgia LLC "Neolab" Tbilisi
Hong Kong Prince Of Wales Hospital - The Chinese University Of Hong Kong Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Poland Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spólka Partnerska Gdansk
Poland ID Clinic Arkadiusz Pisula Myslowice
Poland Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spólka Partnerska Wroclaw
Romania Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase Bucharest
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Taiwan Chia-yi Christian Hospital Chia-Yi City
Taiwan Kaohsiung Medical University Chung-ho Memorial Hospital Kaohsiung City
Taiwan China Medical University Hospital Taichung City
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei City
Thailand 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
United Kingdom Imperial College Hospital London
United Kingdom Royal London Hospital London
United Kingdom Royal London Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Arbutus Biopharma Corporation

Countries where clinical trial is conducted

Georgia,  Hong Kong,  Poland,  Romania,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time • Measurement of soluble immune marker levels in plasma at multiple timepoints Up to 48 Weeks
Secondary 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
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