Hepatitis B, ChronicPhase 2NCT06245291
Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection
A Phase 2 study testing Imdusiran and Durvalumab in people with Hepatitis B, Chronic, run by Arbutus Biopharma Corporation at 22 sites in 8 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Imdusiran and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 1 May 2024to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 18-65
- Willing and able to provide informed consent
- Willing to follow protocol-specified contraception requirement
Who cannot join
- 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.
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
Taiwan5 sites
Chia-yi Christian Hospital
Chia-Yi City
Kaohsiung Medical University Chung-ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Thailand5 sites
King Chulalongkorn Memorial Hospital
Bangkok
Siriraj Hospital
Bangkok
The Hiv Netherlands Australia Thailand Research Collaboration
Bangkok
Srinagarind Hospital
Khon Kaen
Naresuan University Hospital
Phitsanulok
Poland3 sites
Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska
Gdansk
ID Clinic Arkadiusz Pisula
Mysłowice
Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska
Wroclaw
Georgia2 sites
Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0160
LLC "Neolab"
Tbilisi, 0186
Hong Kong2 sites
Prince Of Wales Hospital - The Chinese University Of Hong Kong
Hong Kong
Queen Mary Hospital
Hong Kong
Spain2 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
United Kingdom2 sites
Imperial College Hospital
London
Royal London Hospital
London
Romania1 site
Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase
Bucharest
About this study
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
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
- Conditions
- Hepatitis B, Chronic
- Being tested
- Imdusiran, Durvalumab
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImdusiranDrug
subcutaneous injection
DurvalumabDrug
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints Receives: Drug: Imdusiran; Drug: Durvalumab |
| Cohort B | Experimental | Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints Receives: Drug: Imdusiran; Drug: Durvalumab |
| Cohort C | Experimental | Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints Receives: Drug: Imdusiran; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 96 weeks
Secondary outcomes (3)
To determine the effect of imdusiran and durvalumab on HBsAg
- Change in HBsAg levels from baseline during treatment and follow-up
Measured: Up to 96 Weeks
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
Measured: 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
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 May 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbutus Biopharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245291
- Sponsor's protocol ID
- AB-729-203
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06245291
- Acronym / sponsor ID
- AB-729-203
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arbutus Biopharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Imdusiran, Drug: DurvalumabImdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints |
| Cohort B | Experimental | Drug: Imdusiran, Drug: DurvalumabImdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints |
| Cohort C | Experimental | Drug: Imdusiran, Drug: DurvalumabImdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imdusiransubcutaneous injection | Drug | Cohort A, Cohort B, Cohort C |
| Durvalumabintravenous injection | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects
Time frame: 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
3 secondary outcomes
To determine the effect of imdusiran and durvalumab on HBsAg
Time frame: Up to 96 Weeks
To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time
Time frame: Up to 48 Weeks
To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48
Time frame: Up to Week 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imdusiran and Durvalumab in people with Hepatitis B, Chronic, run by Arbutus Biopharma Corporation at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Taiwan, Thailand, Poland, Georgia, Hong Kong and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects (time frame: Up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.