Phase 2 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 65 years old
• You have had a chronic Hepatitis B infection (confirmed by a positive HBsAg blood test for more than 6 months)
• Your Hepatitis B surface antigen (HBsAg) level falls within a specific range (300–10,000 IU/mL) on a blood test
• You have been on a stable Hepatitis B antiviral medication for more than 1 year
• Your Hepatitis B virus levels in the blood have been very low (below 60 IU/mL) on two separate tests at least 12 weeks apart
• Your liver enzyme levels (ALT) have been within the normal range on two separate tests at least 12 weeks apart
• If you are a woman who could become pregnant, you must have a negative pregnancy test, not be breastfeeding, and be willing to use highly effective contraception during the study; you must also agree not to donate eggs or pursue IVF during the study
• If you are a man with a female partner who could become pregnant, you must agree to use effective contraception during the study and not donate sperm during the study
• You are willing and able to give your signed consent to participate

Who may not be able to join:

• You have been diagnosed with cirrhosis (severe liver scarring), confirmed by a liver scan, liver biopsy, or signs of serious liver complications such as fluid build-up in the abdomen or confusion caused by liver disease
• You have a current or past diagnosis of liver cancer (hepatocellular carcinoma)
• You also have Hepatitis C or Hepatitis D infection
• You are living with HIV
• You are pregnant or currently breastfeeding
• Your liver enzyme (ALT) level is above 45 U/L
• You have another chronic liver disease (other than Hepatitis B or simple fatty liver seen on ultrasound)
• You have used a specific type of Hepatitis B treatment called peginterferon in the past 12 months
• You have taken immune-suppressing medications at a significant dose (equivalent to 10 mg or more of prednisone daily) in the past 6 months
• You have certain other serious health conditions, including significant lung problems in the past 6 months, most types of cancer in the past 5 years, or a condition that weakens your immune system
• You have taken part in another clinical trial or received an experimental drug or vaccine within the past 90 days (or longer, depending on the drug)
• The trial doctor believes that participating would not be in your best interest or could affect how the trial results are measured
• Your platelet count (cells that help blood clot) is below a certain level
• Your blood clotting time (INR) is above 1.3, suggesting a clotting problem
• Your bilirubin level (a substance produced by the liver) is above a certain level
• Your haemoglobin (the part of blood that carries oxygen) is too low — below a specific level for women or men
• Your kidney function is below a certain level (eGFR less than 45 cc/min)
• A protein called alpha-fetoprotein (AFP), which can be a marker for liver cancer, is above 50 ng/mL
• You have previously had a liver transplant or any other solid organ transplant
• You are currently taking blood-thinning medication or have a condition that affects your blood's ability to clot
• You have a blood disorder such as thalassaemia or sickle cell disease
• You have another significant liver condition such as alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, or alpha-1 antitrypsin deficiency
• You are unable to give your informed consent to participate

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