Phase 4 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:

• Adults between 18 and 85 years old who have cirrhosis (scarring of the liver) from any cause, or who have chronic hepatitis B with a liver cancer risk score (called PAGE-B) above 9, measured within the past 12 months
• People whose treating doctor or the trial site considers them appropriate for regular liver cancer monitoring (surveillance)
• People who are able to give their informed consent to participate
• People whose treating doctor or trial site estimates they have a life expectancy of more than 6 months at the time of consent

Who may not be able to join:

• People with the most severe stage of liver scarring, known as Child Pugh C cirrhosis
• People who have had, or currently have symptoms of, liver cancer (hepatocellular carcinoma) or bile duct cancer (cholangiocarcinoma)
• People who had a solid growth of 1 cm or larger found on a liver ultrasound in the 9 months before consent, unless a CT or MRI scan has since confirmed it is not cancerous
• People with a raised liver cancer blood marker (AFP above 20 ng/mL) in the 6 months before consent, unless a CT or MRI scan around that same time showed no suspicious liver growths
• People newly diagnosed with a specific category of liver lesion (called LR-3, meaning a growth of 1 cm or more) within the 6 months before consent
• People with a history of higher-risk liver lesion categories (LR-4, LR-5, or LR-M) found on a CT or MRI scan within the 6 months before consent
• People who have had another active cancer in the past 2 years, other than certain low-risk skin cancers or slow-growing cancers already being monitored (such as some types of prostate or kidney cancer)
• People whose doctor is already planning to use MRI or CT scans as their ongoing liver monitoring method
• People who have had a procedure called a TIPS (a shunt placed inside the liver to manage blood pressure)
• People with liver disease caused by a specific heart condition known as Fontan-associated liver disease or cardiac cirrhosis
• People who have previously received a solid organ transplant (such as a kidney, heart, or liver)
• People who are currently on an active waiting list for a liver transplant
• People diagnosed with alcohol-associated hepatitis within the 3 months before consent
• People currently showing active signs of a condition called acute Wilson disease (a genetic copper disorder causing liver failure, neurological symptoms, or blood cell breakdown)
• People with a condition called primary sclerosing cholangitis (PSC) who have had an active bile duct infection (cholangitis) within the 90 days before consent
• People with a documented history of not following through with medical studies or procedures, or who are unwilling to follow the trial's requirements
• People living with HIV whose immune cell count (CD4+ T cell count) was below 100 cells/mm³ within the 60 days before consent
• People who are known to be pregnant at the time of consent
• People currently taking the blood-thinning medication warfarin

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