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 who are able to fully understand and sign the consent form for the trial.
• Men or women between 18 and 65 years of age (inclusive).
• People whose body mass index (a measure of body weight relative to height) falls within the range set by the trial.
• People who have had chronic hepatitis B, shown by a positive hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV) in the blood, for at least 6 months before the screening visit.
• People whose hepatitis B markers and liver enzyme levels at screening fall within the ranges set by the trial, based on whether they have previously taken hepatitis B antiviral tablets or are treatment-naive (confirm with trial site for specific values).
• People who are willing and able to use effective contraception as required by the trial.

Who may not be able to join:

• People with a history of a serious ongoing illness or any cancer other than chronic hepatitis B, which the trial doctor considers would make participation unsafe.
• People who have previously had a solid organ transplant (such as a kidney or liver) or a stem cell transplant.
• People with a history of any other liver disease, or a history of autoimmune disease or conditions that may affect the immune system, that the trial doctor considers unsuitable.
• People who have had or currently have signs of the liver failing to function properly (hepatic decompensation).
• People with a history of primary liver cancer, or where liver cancer is diagnosed or suspected at the time of screening.
• People with evidence of significant liver scarring or cirrhosis found through scans or biopsy within the 12 months before screening, or detected by a liver stiffness test at screening.
• People who have had a major injury or major surgery within 12 weeks before screening.
• People with a history of severe allergies (for example, to two or more allergens) or a severe allergy to any ingredient in the study drug, or where the trial doctor considers this makes participation unsuitable.
• People who have had a serious infection requiring intravenous antibiotics or antiviral treatment (other than for hepatitis B) within 2 weeks before screening.
• People with a history of drug abuse or alcohol dependence.
• People who have donated blood or experienced significant blood loss within 12 weeks before screening, or who plan to donate blood during the trial.
• People who have used immune-suppressing, immune-modifying, cytotoxic, or biologic medicines within 6 months before screening.
• People who have used any oligonucleotide-based medicines or interferon therapy within 12 months before screening.
• People who have received a vaccination within 4 weeks before screening, or who plan to be vaccinated during the trial.
• People who have tattoos, active skin conditions, or other skin issues that may interfere with under-the-skin injections or the ability to monitor injection sites.
• People with a clinically significant abnormal heart tracing (ECG) at screening.
• People who test positive for HIV, hepatitis C (HCV), or active syphilis.
• People with high blood pressure that is not well controlled at the time of screening.
• People with abnormal blood test results at screening that fall outside the ranges specified in the trial protocol (confirm with trial site for specific values).
• People who are currently taking part in another clinical trial, or who are still within a required waiting period after a previous trial.
• People who have any other condition that the trial doctor considers would make participation unsuitable.

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