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Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B — i-LIVER  

Chronic Hepatitis B Clinical Trial

Official title:
Pilot Study to Evaluate Intrahepatic and Peripheral Responses to Small Interfering RNA, Imdusiran (AB-729), Among People With Chronic Hepatitis B

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06154278
Study type Interventional
Source University of Maryland, Baltimore
Contact Lydia SY Tang, MBChB
Phone +1(410)-706-6567
Email lydiatang@ihv.umaryland.edu
Status Not yet recruiting
Phase Phase 2
Start date July 1, 2024
Completion date July 1, 2027
View Details
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