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:

• People aged 18 or older at the time of screening
• People who are in good general health based on their medical history
• People who have been diagnosed with chronic hepatitis B infection, meaning a specific protein called HBsAg has been detected in their blood at screening and for at least 6 months before screening
• People who have been taking an approved oral antiviral medication for hepatitis B for at least 6 months and are willing to continue taking it throughout the study
• People whose hepatitis B virus levels in the blood have been very low (at or below 20 IU/mL) for 6 or more months before screening
• People whose hepatitis B surface antigen levels are at or above 100 IU/mL at screening
• People who have had a liver scan within the past 12 months showing no signs of liver cancer, and a blood protein marker for liver cancer (alpha fetoprotein) below 10 ng/mL within 3 months of screening
• People who are willing to follow all study procedures and remain available for the full duration of the study
• People who sign and date a consent form agreeing to take part
• Women who could become pregnant must have a negative pregnancy test at both the screening visit and the baseline visit before receiving the study treatment
• People who are sexually active with a partner of the opposite sex and could potentially conceive must agree to use contraception methods specified by the study protocol

Who may not be able to join:

• People who also have HIV, hepatitis C (unless they have completed treatment for hepatitis C and the virus is no longer detectable), or hepatitis D
• People who have a pre-existing medical or psychiatric condition that could affect their ability to consent or take part in the study
• People who have ever had cirrhosis (scarring of the liver), or who have signs of serious liver disease such as fluid build-up in the abdomen, bleeding in the food pipe, kidney problems related to liver disease, a liver transplant, or confusion caused by liver problems
• People whose liver scans have ever shown signs that could suggest liver cancer
• People who have had an unstable medical condition in the 2 weeks before the first dose of the study treatment
• People who have been diagnosed with substance misuse involving alcohol, narcotics, or cocaine in the past 12 months, unless they are enrolled in a monitored opioid replacement program
• People who have had cancer in the past 5 years, except for certain cancers fully removed by surgery (such as basal cell skin cancer); people currently being assessed for a possible cancer diagnosis are also not eligible
• People with significant liver scarring or fibrosis, as measured by liver biopsy, a specialised blood test (FibroTest and APRI), or a liver stiffness scan (FibroScan) — the study has specific score thresholds for each of these tests (confirm with trial site)
• People whose blood test results at screening fall outside acceptable ranges, including liver enzyme levels (ALT), bilirubin, blood clotting time, platelet count, or kidney function (confirm with trial site for specific values)
• People with significant heart, lung, or neurological conditions, as determined by the study investigator
• People who have taken part in another clinical trial of a drug, vaccine, or device within 30 days before starting this study (or 90 days if the previous trial involved a biologic treatment), or who are currently in another trial
• Women who are pregnant or breastfeeding
• People the study investigator considers unsuitable for any other reason

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