Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

NCT ID: NCT06245291

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A

Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints

Group Type EXPERIMENTAL

Imdusiran

Intervention Type DRUG

subcutaneous injection

Durvalumab

Intervention Type DRUG

intravenous injection

Cohort B

Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints

Group Type EXPERIMENTAL

Imdusiran

Intervention Type DRUG

subcutaneous injection

Durvalumab

Intervention Type DRUG

intravenous injection

Cohort C

Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints

Group Type EXPERIMENTAL

Imdusiran

Intervention Type DRUG

subcutaneous injection

Durvalumab

Intervention Type DRUG

intravenous injection

Interventions

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Imdusiran

subcutaneous injection

Intervention Type DRUG

Durvalumab

intravenous injection

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arbutus Biopharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, , Georgia

Site Status

LLC "Neolab"

Tbilisi, , Georgia

Site Status

Prince Of Wales Hospital - The Chinese University Of Hong Kong

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska

Gdansk, , Poland

Site Status

ID Clinic Arkadiusz Pisula

Mysłowice, , Poland

Site Status

Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska

Wroclaw, , Poland

Site Status

Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase

Bucharest, , Romania

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Chia-yi Christian Hospital

Chia-Yi City, , Taiwan

Site Status

Kaohsiung Medical University Chung-ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

The Hiv Netherlands Australia Thailand Research Collaboration

Bangkok, , Thailand

Site Status

Srinagarind Hospital

Khon Kaen, , Thailand

Site Status

Naresuan University Hospital

Phitsanulok, , Thailand

Site Status

Imperial College Hospital

London, , United Kingdom

Site Status

Royal London Hospital

London, , United Kingdom

Site Status

Countries

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Georgia Hong Kong Poland Romania Spain Taiwan Thailand United Kingdom

Other Identifiers

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AB-729-203

Identifier Type: -

Identifier Source: org_study_id

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