Phase 3 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 fully understand the study, are joining voluntarily, and have signed the consent form.
• You are 18 years old or older, any gender.
• You have a confirmed diagnosis of liver scarring (fibrosis) or advanced liver scarring (cirrhosis), shown either by a liver biopsy taken within the past year, or by a liver scan (such as Fibroscan or ultrasound) taken within the past 3 months.
• Your liver enzyme levels (specifically ALT) are not too highly elevated — below 8 times the normal upper limit.
• If you are a woman who could become pregnant, you have a negative pregnancy test and agree to use highly effective birth control from the start of the trial until 6 months after your last dose of the study drug.

Who may not be able to join:

• You have had a serious bleeding episode in your upper digestive tract in the past 3 months, or you currently have a digestive condition that could affect how your body absorbs medication.
• Your bilirubin levels (a measure of liver health) are too high — more than 3 times the normal upper limit, or above 2 times the normal limit alongside certain elevated liver enzyme levels (confirm with trial site).
• Your AFP level (a protein sometimes linked to liver cancer) is above 100 μg/L, even if there are no signs of liver cancer.
• Your blood platelet count is too low, or your blood clotting ability is outside the acceptable range (confirm with trial site for specific numbers).
• You have had an active infection (bacterial, viral — other than hepatitis B or C — fungal, or parasitic) within the past 4 weeks, or have needed antibiotic or antiviral treatment for any infection recently.
• You have tested positive for HIV.
• You have a history of cancer, or significant problems with your heart, lungs, or kidneys, or severe liver complications beyond what your liver disease would normally cause (such as signs of your liver no longer working properly).
• You are currently pregnant or breastfeeding.
• You have taken part in another clinical trial and received an experimental drug within the past 3 months.
• The trial doctor believes there is any other reason you may not be suitable or may not be able to complete the study.

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