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Antisense Oligonucleotide
Imdusiran for Chronic Hepatitis B (i-LIVER Trial)
Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit.
Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how well Imdusiran works in the liver of people with chronic hepatitis B and how it affects the hepatitis B virus. Participants will receive injections of Imdusiran every
Who is the study for?
This trial is for adults over 18 with chronic hepatitis B who've been on HBV oral antiviral treatments for at least 6 months and have a certain level of hepatitis B surface antigen. They must be in good health, not pregnant, willing to continue their current treatment, and use contraception if applicable.
What is being tested?
The trial studies Imdusiran (AB-729) effects on the liver and hepatitis B virus. Participants will get one injection every 8 weeks for a total of four doses and undergo two liver biopsies—one at the start and another after the final dose.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, changes in liver function tests, fatigue or flu-like symptoms as common with injections targeting viral infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on HBV medication for 6 months and can continue it.
Select...
I have been positive for hepatitis B for more than 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intrahepatic concentration of Imdusiran (AB-729)
Secondary study objectives
Effect of Imdusiran (AB-729) on hepatitis B e antibody serostatus
Effect of Imdusiran (AB-729) on hepatitis B e antigen serostatus
Effect of Imdusiran (AB-729) on hepatitis B surface antibody levels
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Imdusiran (AB-729)Experimental Treatment1 Intervention
Participants receive subcutaneous injections of 60mg, one injection every 8 weeks for 4 doses.
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Who is running the clinical trial?
Arbutus Biopharma CorporationIndustry Sponsor
12 Previous Clinical Trials
632 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,482 Total Patients Enrolled
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