Phase 1 Hepatitis B Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 to 70 years old
• People who have had a confirmed hepatitis B (HBV) infection for at least 6 months, shown by a positive HBsAg blood test
• People who have been taking an approved hepatitis B antiviral medication for at least 6 months, with no change to that medication in the last 3 months
• People whose hepatitis B virus levels in the blood are undetectable at the time of testing (up to 49 days before the study starts)
• People whose blood tests show they are negative for hepatitis B surface antibody and negative for HBeAg (a hepatitis B marker) at the time of testing
• People who are willing and able to give informed consent to participate
• People who could become pregnant must have a negative pregnancy test at screening and at the start of the study
• People who could become pregnant must agree to use two forms of contraception (at least one from a highly effective method, such as an implant, IUD, combined oral contraceptive pill, injectable contraceptive, vaginal ring, contraceptive patch, or a partner with documented sterilisation) starting 10 days before the study begins and throughout the follow-up period
• People who could make a partner pregnant 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 have signs of advanced liver scarring (fibrosis grade 3 or 4), based on a liver stiffness scan (FibroScan) showing a result of 9 kPa or above, done within the last 12 months or at the pre-study visit
• People who have a liver lesion rated as LI-RADS 4 or 5 (a category suggesting possible liver cancer) on a scan done within the last 12 months or at the pre-study visit
• People with a blood protein called alpha-fetoprotein above 20 ng/mL (a marker sometimes associated with liver cancer)
• People with HIV, hepatitis C, or hepatitis delta virus infection, tested within the last 12 months or at screening
• People who have previously had a bone marrow (stem cell) transplant or a solid organ transplant
• People with a history of significant allergic reactions to any medication, monoclonal antibody, or vaccine, or who have allergies to multiple drugs
• People with a history of heart disease, including heart failure, coronary artery disease, cardiomyopathy, or a family history of inherited heart rhythm disorders or sudden death
• People with clinically significant abnormal heart rhythm readings (ECG results), such as certain measurements outside accepted ranges
• People who have used corticosteroids (steroids), immune-suppressing cancer medications, interferons, or interleukins within the last 6 months
• People with a history of chronic liver disease from a cause other than hepatitis B, certain immune conditions, or autoimmune diseases that the study doctor believes would make participation unsafe
• People who have had a significant infection (such as flu or COVID-19) or another serious illness within the 2 weeks before the study starts
• People with certain abnormal blood test results, including low white blood cell counts, low red blood cell levels, low platelet counts, elevated liver enzymes, abnormal bilirubin, low albumin, reduced kidney function, or abnormal blood clotting results
• People who are pregnant or breastfeeding
• People who have received any vaccination in the 2 weeks before the study starts
• People who have ever received anti-hepatitis B antibody therapy of any kind, including hepatitis B immunoglobulin (HBIG)
• People currently participating in another clinical trial of an investigational treatment, or who have done so within the 12 weeks before this study, or who are expected to do so during this study

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