Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154278
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-10-31
Brief Title:
Intrahepatic and Peripheral Responses to Imdusiran AB-729 in Chronic Hepatitis B
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pilot Study to Evaluate Intrahepatic and Peripheral Responses to Small Interfering RNA Imdusiran AB-729 Among People With Chronic Hepatitis B
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
i-LIVER
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None