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New treatment option for Chronic Hepatitis B
Official title Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
ClinicalTrials.gov ID: NCT06154278
What this study is testing
What is Imdusiran (AB-729)?
Imdusiran (AB-729) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic hepatitis b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Known co-infection with any of the following:
- Human immunodeficiency virus (HIV)
- Hepatitis C virus (HCV), unless people 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...
- History of cirrhosis at any time, or evidence of decompensated liver disease including, but not limited to, a history or presence of clinical...
See the full eligibility criteria
- 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 people 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.
- Known co-infection with any of the following:
- Human immunodeficiency virus (HIV)
- Hepatitis C virus (HCV), unless people 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...
- 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 people 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). people 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...
- If liver biopsy is available, the liver biopsy result supersedes (i) and (ii).
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.