Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Maryland, Baltimore
You may qualify if…
- ✓ 1. Provision of signed and dated informed consent form
- ✓ 2. Stated willingness to comply with all study procedures and availability for the duration of the study
- ✓ 3. Male or female, over 18 years of age on the date of screening
- ✓ 4. In good general health as evidenced by medical history
- ✓ 5. Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)
- ✓ 6. 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
- ✓ 7. Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- ✓ 8. Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit.
You may not qualify if…
- ✕ 1. Known co-infection with any of the following:
- ✕ 1. Human immunodeficiency virus (HIV)
- ✕ 2. Hepatitis C virus (HCV), unless subjects are HCV Ab positive, but have a documented history of completing HCV treatment and/or negative HCV RNA
- ✕ 3. Hepatitis D virus (HDV)
- ✕ 2. 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
- ✕ 3. 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.
- ✕ 4. Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.
- ✕ 5. Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment.
Where it's recruiting
Baltimore
Source: ClinicalTrials.gov · NCT06154278 · last updated 2025-09-11