Phase 2 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 35 to 65 years old (men or women) who are able to follow the study plan and communicate well with the research team
• People who are willing and able to sign a consent form after being fully informed about the study, including its content, steps, and possible side effects
• People who have no plans to have children in the next year and who agree to use contraception methods specified by the trial from the screening stage until 6 months after their last dose
• Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (a measure of weight relative to height) between 18.0 and 35.0
• People who have been on a stable hepatitis B antiviral medication (called nucleoside/nucleotide analogue, or NA therapy) for more than 6 months, and have stayed on the same medication for at least 3 months before entering the study
• People who have had at least two tests during the screening period (more than one week apart) showing that the hepatitis B virus level in their blood is below the lowest detectable level
• People who test negative for HBeAg (a hepatitis B marker), have a specific range of hepatitis B surface antigen (HBsAg) levels between 100 and 1500 IU/mL, and have normal liver enzyme (ALT) levels during screening
• People whose results from vital signs checks, physical examinations, and heart trace (ECG) tests during screening and the start of the study show nothing of medical concern

Who may not be able to join:

• People who have had an allergic reaction to any ingredient in the study drug
• People who cannot tolerate blood draws, or who have a history of fainting at the sight of needles or blood
• People who have had a major injury or major surgery in the 3 months before screening, or who plan to have surgery during the study
• People who have donated blood, lost 400 mL or more of blood, or received a blood transfusion in the 3 months before screening, or who have lost 200 mL or more of blood in the month before screening
• People with a history of alcohol or drug abuse or dependence
• People who have taken part in a clinical trial of a drug or medical device within the 3 months before starting the study
• People who have used any hepatitis B treatment other than their current antiviral (NA) medication in the year before starting the study
• People who have used immune-suppressing or immune-modifying medicines (other than interferon) or chemotherapy-type drugs in the 6 months before screening, or who received a live vaccine in the month before screening
• People with a significant liver disease caused by something other than hepatitis B, where the study doctor considers them unsuitable for the trial
• People with a history of cirrhosis (scarring of the liver), confirmed by liver biopsy or by an internal examination showing enlarged veins in the oesophagus or stomach
• People with confirmed or suspected advanced (decompensated) cirrhosis from hepatitis B, including conditions such as brain problems related to liver failure, kidney failure linked to liver disease, bleeding from enlarged veins, enlarged spleen, fluid build-up in the abdomen, or liver cancer
• People who have been diagnosed with cancer, or who have had a cancer diagnosis in the past 5 years (with the exception of certain treated skin cancers or early-stage cervical cancer that have been fully cured)
• People with stomach or digestive problems that might affect how the body absorbs tablets, such as severe ulcers, serious gastritis, partial stomach removal, or significant nausea, vomiting, or diarrhoea at the time of screening
• People who have had a suspected or confirmed acute infection in the 2 weeks before being enrolled into the study
• People whose blood test results fall outside acceptable ranges for this study, including low platelet count, low white blood cell count, low neutrophil count, high bilirubin levels, low albumin, reduced kidney function, or abnormal blood clotting results (confirm with trial site for specific values)
• People with elevated blood levels of a liver protein called AFP above 50 ng/mL, or whose imaging scans suggest a possible liver tumour
• People who test positive for hepatitis C, syphilis, or HIV
• Women who are breastfeeding, or who have a positive pregnancy test at screening or at the start of the study
• People whom the study doctor considers unsuitable for the trial for any other reason

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