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 between 18 and 65 years old (inclusive)
• People with a body mass index (a measure of body weight relative to height) between 18 and 32
• People who have been diagnosed with chronic hepatitis B infection, meaning a specific protein marker (HBsAg) has been present in their blood for more than 6 months and is still detectable at the screening appointment
• People who have only been taking a specific type of antiviral medication (called nucleoside or nucleotide analog therapy) in the 12 months before screening, and who are still taking it regularly
• People whose hepatitis B virus level in the blood is below 100 IU/ml (a very low level)
• People whose HBsAg level (a hepatitis B marker in the blood) is below 1500 IU/ml

Who may not be able to join:

• People who also have HIV, hepatitis D (HDV) infection, or who have had a liver biopsy in the past 6 months showing significant scarring or advanced liver disease
• People without a recent liver biopsy who have liver stiffness or scarring results above certain thresholds on specialised liver health tests done within 6 months of screening (confirm with trial site)
• People with a liver enzyme level (ALT) more than 3 times the normal upper limit
• People with a blood clotting test result (INR) above 1.5, which may suggest the liver is not working well
• People with a low blood protein (albumin) level below 3.5 g/dl
• People with an elevated bilirubin level (a waste product processed by the liver) more than 1.5 times the normal upper limit
• People with a low platelet count (below 100,000 per microlitre), platelets being the cells that help blood clot
• People with a history of serious liver failure (such as fluid build-up in the abdomen, confusion caused by liver disease, or bleeding from swollen veins in the food pipe), or a prior diagnosis of liver cancer
• People with serious ongoing or past heart, lung, hormonal, immune, or other health conditions that the trial doctors consider unsuitable for participation — including conditions such as unstable heart disease, severe high blood pressure, asthma, chronic lung disease, diabetes, poorly controlled thyroid disease, autoimmune disease, active tuberculosis, cancer, or a history of neurological or psychiatric disorders
• People who have taken part in any other clinical trial of a drug or medical device within the 3 months before joining this trial
• People who have had an organ transplant in the past (except corneal or hair transplants)
• People with a long history of heavy alcohol use (more than 5 years of drinking above 40g of alcohol per day for men, or 20g per day for women) or known dependence on drugs
• People who are planning to have a baby, donate sperm or eggs, or who are unwilling to use effective contraception during the screening period, throughout the trial, and for 6 months after the trial ends

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