Early 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:

• You are between 18 and 60 years old (including both ages), of any sex
• You have tested positive for the hepatitis B surface antigen (a marker of hepatitis B infection) for more than 6 months
• If you are already on antiviral medication for hepatitis B: you have been taking it continuously for more than 6 months, your hepatitis B surface antigen level is at or above 1500 IU/ml, and the amount of hepatitis B virus in your blood is very low (below 500 IU/ml) at the time of joining
• If you have not yet been treated: your hepatitis B surface antigen level is above 1500 IU/ml and you meet the treatment criteria set out in the 2019 Chinese guidelines for chronic hepatitis B (confirm with trial site)
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 24 hours before your first dose

Who may not be able to join:

• You currently have an active infection with hepatitis A, C, D, E, or HIV alongside hepatitis B
• You are currently taking, or plan to continue taking, a medication called telbivudine
• Your alpha-fetoprotein (a liver marker) level is above 100 ng/ml at screening, or it has not been stable for the 3 months before the trial, or a liver scan suggests a possible liver tumour (confirm with trial site)
• You have serious liver disease that is no longer working properly, shown by any of the following: your blood clotting time is significantly prolonged, your bilirubin (a liver chemical) is too high, or you have a history of mental confusion caused by liver failure, bleeding from veins in your food pipe, or fluid build-up in your abdomen
• You are pregnant, breastfeeding, planning to become pregnant during the study, or unwilling to use contraception
• Your white blood cell count (a type called neutrophils) or platelet count is too low, or your kidney function marker (creatinine) is too high (confirm with trial site for exact numbers)
• You have a history of serious mental illness, particularly severe depression, psychosis, suicide attempts, or have been hospitalised due to a psychiatric condition
• You have a history of a disease where your immune system attacks your own body (such as lupus, rheumatoid arthritis, inflammatory bowel disease, or severe psoriasis), or you have abnormally high levels of certain immune markers in your blood
• You have serious disease affecting your heart, lungs, kidneys, brain, or blood, or you have any other type of cancer
• You have a history of serious epilepsy or are currently taking anti-epilepsy medications; your diabetes, high blood pressure, or thyroid condition is not well controlled; or you have a history of serious eye (retina) disease
• You have previously had an organ transplant and still have a functioning transplanted organ (corneal or hair transplants are excepted)
• You are allergic to interferon or any of its ingredients, or the trial doctor does not think interferon is appropriate for you
• The trial doctor considers you unsuitable for the study for any other reason

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