Phase 1 Hepatitis B Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 70 years old
• People who have had a confirmed hepatitis B (HBV) infection for at least 6 months, shown by a positive HBsAg test
• People who have been taking an antiviral medication for hepatitis B for at least 6 months, with no change to that medication in the past 3 months
• People whose hepatitis B virus levels in the blood are too low to be measured by standard tests
• People whose HBsAg level is above 10 IU/mL and whose hepatitis B surface antibody test is negative
• People who are willing and able to give informed consent to participate
• People who could become pregnant must have a negative pregnancy test at both the screening visit and the start of the study
• People who could become pregnant must agree to use two methods of contraception during the study (one option is a partner who has documented proof of a vasectomy with confirmed zero sperm count, provided that partner is their only partner)
• People who could father a pregnancy must agree to use condoms starting 10 days before the study begins and throughout the follow-up period

Who may not be able to join:

• People who show signs of advanced liver scarring (stage 3 or 4 fibrosis), based on a liver stiffness scan (FibroScan) result of 9 kPa or higher, done within the past 12 months or at the pre-treatment visit
• People who have a certain type of suspicious liver lesion (classified as LI-RADS 4 or 5) found on a scan within the past 12 months or at the pre-treatment visit
• People with a blood protein level called alpha-fetoprotein (AFP) above 20 ng/mL (confirm with trial site regarding borderline results)
• People who have HIV, hepatitis C, or hepatitis delta virus infection, based on tests within the past 12 months or done at screening
• People who have previously had a bone marrow or stem cell transplant, or a solid organ transplant (such as a kidney or liver transplant)
• People who have had a significant allergic reaction (such as hives or anaphylaxis) to any drug, antibody therapy, or vaccine, or who have multiple drug allergies
• People with a history of heart disease, including heart failure, coronary artery disease, cardiomyopathy, or a family history of certain inherited heart rhythm conditions
• People who have a clinically significant abnormal heart rhythm reading (ECG), including a QTcF interval above 450 ms for males or above 470 ms for females
• People who have used systemic steroids, immune-suppressing cancer medications, interferons, or interleukins in the past 6 months
• People with a history of chronic liver disease from a cause other than hepatitis B, or certain immune or autoimmune conditions (the trial doctor would make this assessment)
• People who have had a significant acute illness, such as influenza or COVID-19, within the 2 weeks before the study start date
• People whose blood test results fall outside the acceptable ranges for certain measures, including low white blood cell counts, low haemoglobin, low platelets, elevated liver enzymes (ALT or AST), elevated bilirubin (unless due to a known condition called Gilbert's syndrome), low albumin, reduced kidney function, or a raised INR
• People who are currently pregnant or breastfeeding
• People who have received any vaccine within 14 days before receiving the study treatment
• People who have previously received any anti-hepatitis B antibody therapy, including hepatitis B immune globulin (HBIG)
• People who are currently in another clinical trial of an investigational product, have been in one within the past 12 weeks, or expect to join one during this study

Important: Always verify eligibility with the trial site directly before applying.