Status:
RECRUITING
Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Arbutus Biopharma Corporation
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 conc...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, over 18 years of age on the date of screening
- In good general health as evidenced by medical history
- Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)
- 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
- Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit.
- HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to Screening.
- Hepatitis B surface antigen titer ≥ 100 IU/mL.
- Liver imaging without liver mass suggestive of hepatocellular carcinoma within 12 months of day 0 AND Alpha fetoprotein \<10 ng/mL within 3 months of screening.
Exclusion
- Known co-infection with any of the following:
- Human immunodeficiency virus (HIV)
- Hepatitis C virus (HCV), unless subjects are HCV Ab positive, but have a documented history of completing HCV treatment and/or negative HCV RNA
- Hepatitis D virus (HDV)
- 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
- 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.
- Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.
- Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment.
- Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine within the past 12 months except for those subjects monitored in an opioid substitution maintenance program.
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g. basal cell skin cancer). Subjects under evaluation for possible malignancy are not eligible.
- Extensive bridging fibrosis or cirrhosis as defined clinically, by imaging or by the following:
- a. Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by a liver biopsy within 3 years of screening, or, in the absence of an appropriate liver biopsy, either: i. Screening FibroTest score \>0.48 and APRI \>1, or ii. FibroScan with a result \>9 kPa within 12 months of screening
- If liver biopsy is available, the liver biopsy result supersedes (i) and (ii).
- Subjects meeting any of the following laboratory parameters at screening:
- Alanine aminotransferase (ALT) \>3x Upper Limit of Normal (ULN)
- Direct bilirubin (if total bilirubin elevated) \>1.5 × ULN of the laboratory reference range.
- Prothrombin (PT) or Activated Partial Thromboplastin Clotting Time (APTT) over the upper limit of normal.
- Platelet count \<100,000/microliters
- Estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \<60 mL/min/1.73 m2
- Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.
- Participation in any investigational drug, vaccine, or device study within 30 days before study treatment administration, or 90 days for a biologic study, or at any time during participation in the study.
- Pregnancy or lactation
- Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06154278
Start Date
July 25 2024
End Date
July 1 2027
Last Update
September 11 2025
Active Locations (1)
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1
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201