RECRUITING

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

Conditions

Chronic Hepatitis B hepatitis B SiRNA liver biopsy Imdusiran

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-25

Study Completion:2027-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06154278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, over 18 years of age on the date of screening 4. In good general health as evidenced by medical history 5. Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening) 6. 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 7. Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 8. Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit. 9. HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to Screening. 10. Hepatitis B surface antigen titer ≥ 100 IU/mL. 11. 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.	1. Known co-infection with any of the following: 1. Human immunodeficiency virus (HIV) 2. Hepatitis C virus (HCV), unless subjects are HCV Ab positive, but have a documented history of completing HCV treatment and/or negative HCV RNA 3. Hepatitis D virus (HDV) 2. 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 3. 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. 4. Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time. 5. Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment. 6. 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. 7. 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. 8. Extensive bridging fibrosis or cirrhosis as defined clinically, by imaging or by the following: * If liver biopsy is available, the liver biopsy result supersedes (i) and (ii). 9. Subjects meeting any of the following laboratory parameters at screening: 1. Alanine aminotransferase (ALT) \>3x Upper Limit of Normal (ULN) 2. Direct bilirubin (if total bilirubin elevated) \>1.5 × ULN of the laboratory reference range. 3. Prothrombin (PT) or Activated Partial Thromboplastin Clotting Time (APTT) over the upper limit of normal. 4. Platelet count \<100,000/microliters 5. Estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \<60 mL/min/1.73 m2 10. Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator. 11. 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. 12. Pregnancy or lactation 13. Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, over 18 years of age on the date of screening
4. In good general health as evidenced by medical history
5. Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)
6. 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
7. Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit.
9. HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to Screening.
10. Hepatitis B surface antigen titer ≥ 100 IU/mL.
11. 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.

1. Known co-infection with any of the following:
1. Human immunodeficiency virus (HIV)
2. Hepatitis C virus (HCV), unless subjects are HCV Ab positive, but have a documented history of completing HCV treatment and/or negative HCV RNA
3. Hepatitis D virus (HDV)
2. 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
3. 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.
4. Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.
5. Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment.
6. 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.
7. 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.
8. Extensive bridging fibrosis or cirrhosis as defined clinically, by imaging or by the following:
* If liver biopsy is available, the liver biopsy result supersedes (i) and (ii).
9. Subjects meeting any of the following laboratory parameters at screening:
1. Alanine aminotransferase (ALT) \>3x Upper Limit of Normal (ULN)
2. Direct bilirubin (if total bilirubin elevated) \>1.5 × ULN of the laboratory reference range.
3. Prothrombin (PT) or Activated Partial Thromboplastin Clotting Time (APTT) over the upper limit of normal.
4. Platelet count \<100,000/microliters
5. Estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \<60 mL/min/1.73 m2
10. Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.
11. 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.
12. Pregnancy or lactation
13. Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed

Contacts and Locations

Study Contact

Lydia SY Tang, MBChB

CONTACT

+1(410)-706-6567

lydiatang@ihv.umaryland.edu

Study Locations (Sites)

Institute of Human Virology, University of Maryland School of Medicine

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25

Study Completion Date2027-07-01

Study Record Updates

Study Start Date2024-07-25

Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

hepatitis B
SiRNA
liver biopsy
Imdusiran

Additional Relevant MeSH Terms

Chronic Hepatitis B