Actively Recruiting
Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
Led by University of Maryland, Baltimore · Updated on 2025-09-11
10
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
A
Arbutus Biopharma Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 years or older at screening
- In good general health based on medical history
- Documented chronic hepatitis B infection (HBsAg positive for more than 6 months prior to screening)
- Negative pregnancy tests for females of reproductive potential at screening and baseline
- Agreement to use specified contraception methods if of childbearing potential and sexually active
- On commercially available hepatitis B antiviral treatment for at least 6 months and willing to continue
- Hepatitis B virus DNA level of 20 IU/mL or less for 6 or more months prior to screening
- Hepatitis B surface antigen titer of 100 IU/mL or higher
- Liver imaging within 12 months showing no liver mass suggestive of hepatocellular carcinoma and alpha fetoprotein under 10 ng/mL within 3 months of screening
You will not qualify if you...
- Known co-infection with HIV, hepatitis C (unless treated and RNA negative), or hepatitis D virus
- Any medical or psychiatric condition that interferes with consent or study participation
- History of cirrhosis or signs of decompensated liver disease
- Liver imaging showing hepatocellular carcinoma at any time
- Clinically unstable condition within 2 weeks before first dose
- Substance abuse of alcohol, narcotics, or cocaine in past 12 months except monitored opioid substitution
- Cancer within 5 years except certain skin cancers cured by surgery
- Extensive bridging fibrosis or cirrhosis defined clinically, by imaging, or liver biopsy criteria
- Laboratory abnormalities including ALT higher than 3 times normal, elevated bilirubin, clotting abnormalities, low platelets, or low kidney function
- Significant cardiovascular, lung, or neurological disease
- Participation in other investigational drug, vaccine, or device studies recently
- Pregnancy or breastfeeding
- Investigator judgment deeming participation inappropriate for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
L
Lydia SY Tang, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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