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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
60mg subcutaneously, every 8 weeks, for a total of 4 doses
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, United States
RECRUITINGIntrahepatic concentration of Imdusiran (AB-729)
Intrahepatic drug concentration at day 0 (peak) and week 32 (trough)
Time frame: During intervention (with first dose of Imdusiran) and after intervention (8 weeks after last dose of Imdusiran)
Effect of Imdusiran (AB-729) on hepatitis B surface antigen production
Change in hepatitis B surface antigen titer with Imdusiran
Time frame: 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)
Time frame: Baseline through study completion, an average of 1 year
Effect of Imdusiran (AB-729) on hepatitis B virus RNA
Change in HBV RNA production
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline through study completion, an average of 1 year
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