Chronic Hepatitis BPhase 2i-LIVERNCT06154278
Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
A Phase 2 study testing Imdusiran (AB-729) in people with Chronic Hepatitis B, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are: how well is it working in the liver how does Imdusiran affect the hepatitis B virus Participants will receive injections of Imdusiran, one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Imdusiran (AB-729)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, over 18 years of age on the date of screening
- In good general health as evidenced by medical history
- Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)
- For females of reproductive potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline prior to study drug administration
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- Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit.
- HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to Screening.
- Hepatitis B surface antigen titer ≥ 100 IU/mL.
- Liver imaging without liver mass suggestive of hepatocellular carcinoma within 12 months of day 0 AND Alpha fetoprotein <10 ng/mL within 3 months of screening.
Who cannot join
- Known co-infection with any of the following:
- Human immunodeficiency virus (HIV)
- Hepatitis C virus (HCV), unless subjects are HCV Ab positive, but have a documented history of completing HCV treatment and/or negative HCV RNA
- Hepatitis D virus (HDV)
- Any known preexisting medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study
- History of cirrhosis at any time, or evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, liver transplantation and/or hepatic encephalopathy.
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- Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.
- Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment.
- Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine within the past 12 months except for those subjects monitored in an opioid substitution maintenance program.
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g. basal cell skin cancer). Subjects under evaluation for possible malignancy are not eligible.
- Extensive bridging fibrosis or cirrhosis as defined clinically, by imaging or by the following:
- Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by a liver biopsy within 3 years of screening, or, in the absence of an appropriate liver biopsy, either: i. Screening FibroTest score >0.48 and APRI >1, or ii. FibroScan with a result >9 kPa within 12 months of screening
- If liver biopsy is available, the liver biopsy result supersedes (i) and (ii).
- Subjects meeting any of the following laboratory parameters at screening:
- Alanine aminotransferase (ALT) >3x Upper Limit of Normal (ULN)
- Direct bilirubin (if total bilirubin elevated) >1.5 × ULN of the laboratory reference range.
- Prothrombin (PT) or Activated Partial Thromboplastin Clotting Time (APTT) over the upper limit of normal.
- Platelet count <100,000/microliters
- Estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: <60 mL/min/1.73 m2
- Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.
- Participation in any investigational drug, vaccine, or device study within 30 days before study treatment administration, or 90 days for a biologic study, or at any time during participation in the study.
- Pregnancy or lactation
- Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, 21201
Lisa Anderson, RN, BS, (410) 706-4069, Lisa.anderson@ihv.umaryland.edu
About this study
Official title: Pilot Study to Evaluate Intrahepatic and Peripheral Responses to Small Interfering RNA, Imdusiran (AB-729), Among People With Chronic Hepatitis B
The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are:
- how well is it working in the liver
- how does Imdusiran affect the hepatitis B virus
Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.
Read the detailed description
This is a single-center, non-randomized, pilot study of Imdusiran in adults with chronic hepatitis B on oral antiviral therapy. The primary objective of this study is to evaluate the intrahepatic concentrations of Imdusiran. The secondary objective is to evaluate the effect of Imdusiran on viral markers.
Up to 10 participants will receive a total of 4 subcutaneous injections of 60mg Imdusiran (one injection every 8 weeks). They will undergo 2 liver biopsies: one with the first dose, and the second 8 weeks after the last dose. There is an optional third liver biopsy at the end of study (week 52).
- Conditions
- Chronic Hepatitis B
- Being tested
- Imdusiran (AB-729)
- Keywords
- hepatitis B, SiRNA, liver biopsy, Imdusiran
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imdusiran (AB-729)Drug
60mg subcutaneously, every 8 weeks, for a total of 4 doses
| Study group | Role | What they receive |
|---|---|---|
| Imdusiran (AB-729) | Experimental | Participants receive subcutaneous injections of 60mg, one injection every 8 weeks for 4 doses. Receives: Drug: Imdusiran (AB-729) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatic concentration of Imdusiran (AB-729)
Intrahepatic drug concentration at day 0 (peak) and week 32 (trough)
Measured: During intervention (with first dose of Imdusiran) and after intervention (8 weeks after last dose of Imdusiran)
Secondary outcomes (8)
Effect of Imdusiran (AB-729) on hepatitis B surface antigen production
Change in hepatitis B surface antigen titer with Imdusiran
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B surface antibody levels
Change in hepatitis B surface antigen-specific antibody levels (anti-HBsAg)
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B virus RNA
Change in HBV RNA production
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B virus e antigen production
Change in quantitative HBeAg
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B surface antigen serostatus
Proportion of participants with hepatitis B surface antigen loss
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B surface antibody serostatus
Proportion of participants with anti-HBsAg seroconversion
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B e antigen serostatus
Proportion of participants with HBeAg loss
Measured: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B e antibody serostatus
Proportion of participants with anti-HBeAg seroconversion
Measured: Baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start25 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, non-randomized, pilot study of Imdusiran (AB-729) in virally suppressed adults with chronic hepatitis B on oral antiviral therapy.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Arbutus Biopharma Corporation
- Responsible party
- Principal investigator, Lydia Tang, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154278
- Sponsor's protocol ID
- HP-00106061
- Acronym
- i-LIVER
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Intrahepatic and Peripheral Responses to Small Interfering RNA, Imdusiran (AB-729), Among People With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06154278
- Acronym / sponsor ID
- i-LIVER / HP-00106061
- Conditions
- Chronic Hepatitis B
- Keywords
- hepatitis B, SiRNA, liver biopsy, Imdusiran
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Arbutus Biopharma Corporation
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Dec 2023 (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.
The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are:
- how well is it working in the liver
- how does Imdusiran affect the hepatitis B virus
Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.
Detailed description
This is a single-center, non-randomized, pilot study of Imdusiran in adults with chronic hepatitis B on oral antiviral therapy. The primary objective of this study is to evaluate the intrahepatic concentrations of Imdusiran. The secondary objective is to evaluate the effect of Imdusiran on viral markers.
Up to 10 participants will receive a total of 4 subcutaneous injections of 60mg Imdusiran (one injection every 8 weeks). They will undergo 2 liver biopsies: one with the first dose, and the second 8 weeks after the last dose. There is an optional third liver biopsy at the end of study (week 52).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, non-randomized, pilot study of Imdusiran (AB-729) in virally suppressed adults with chronic hepatitis B on oral antiviral therapy.
| Arm | Type | Receives |
|---|---|---|
| Imdusiran (AB-729) | Experimental | Drug: Imdusiran (AB-729)Participants receive subcutaneous injections of 60mg, one injection every 8 weeks for 4 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, over 18 years of age on the date of screening
- In good general health as evidenced by medical history
- Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)
Key exclusion criteria (23 listed)
- Known co-infection with any of the following:
- Any known preexisting medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study
- History of cirrhosis at any time, or evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, liver transplantation and/or hepatic encephalopathy.
- Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.
- Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment.
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 |
|---|---|---|
| Imdusiran (AB-729)60mg subcutaneously, every 8 weeks, for a total of 4 doses | Drug | Imdusiran (AB-729) |
Primary outcome
Intrahepatic concentration of Imdusiran (AB-729)
Time frame: During intervention (with first dose of Imdusiran) and after intervention (8 weeks after last dose of Imdusiran)
Intrahepatic drug concentration at day 0 (peak) and week 32 (trough)
8 secondary outcomes
Effect of Imdusiran (AB-729) on hepatitis B surface antigen production
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B surface antibody levels
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B virus RNA
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B virus e antigen production
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B surface antigen serostatus
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B surface antibody serostatus
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B e antigen serostatus
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B e antibody serostatus
Time frame: Baseline through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imdusiran (AB-729) in people with Chronic Hepatitis B, run by University of Maryland, Baltimore at 1 site in United States.
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 11 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia SY Tang, MBChB (+1(410)-706-6567, lydiatang@ihv.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic concentration of Imdusiran (AB-729) (time frame: During intervention (with first dose of Imdusiran) and after intervention (8 weeks after last dose of Imdusiran)). 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 11 Sep 2025.