Phase 1 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 have had chronic Hepatitis B infection (specifically the "HBeAg negative" type) for at least 6 months, confirmed by a protein called HBsAg being present in the blood for that time.
• People whose blood shows a specific level of the HBsAg protein — at least 100 but no more than 2,000 units per millilitre — at the screening visit.
• People who have been taking stable antiviral medication for Hepatitis B (called nucleotide analogues) for at least 6 months and are expected to continue, or people who are not taking this type of medication at all.
• People whose Hepatitis B virus levels in the blood are at or below a certain amount at screening — the specific limit depends on whether or not the person is taking antiviral medication (confirm exact level with trial site).
• Male participants who agree not to donate sperm and to use highly effective contraception during the trial.
• Female participants who are not pregnant or breastfeeding, and who either cannot become pregnant or agree to use highly effective contraception during the trial.

Who may not be able to join:

• People who also have Hepatitis C, HIV, or Hepatitis D infection at the time of screening.
• People who weigh less than 50 kilograms or have a body mass index (BMI) below 18.5 (a standard measure of body weight relative to height).
• People with a known history of liver cirrhosis (scarring of the liver), or people still being assessed for cirrhosis — those people would need cirrhosis to be ruled out before eligibility could be considered.
• People whose liver stiffness measurement is above 8 kilopascals at screening, which is a measure used to assess liver health.
• People with a history of other long-term liver disease, immune complex disease, or autoimmune conditions that, in the opinion of the trial doctor, would prevent safe participation.
• People with a family history of liver cancer (hepatocellular carcinoma).
• People with a blood protein level called alpha fetoprotein above 20 nanograms per millilitre, which can be a marker sometimes associated with liver concerns.
• People who have had certain suspicious findings on liver imaging scans — specifically certain higher-risk categories of liver lesions — identified within the 12 months before screening, or before the first treatment visit (confirm details with trial site).
• People who have previously had a bone marrow stem cell transplant or a solid organ transplant (such as a kidney or liver transplant).
• People who have ever received antibody-based treatments targeting Hepatitis B, including a product called hepatitis B immunoglobulin (HBIG).
• People with a history of significant heart conditions such as coronary artery disease, heart failure, or a family history of a condition called congenital long QT syndrome — though stable, well-controlled high blood pressure is generally allowed.
• People who have been diagnosed with or treated for cancer within the past 5 years, or who are currently receiving cancer treatment — with some exceptions for certain minor skin cancers or a type of cervical condition treated with curative intent (confirm with trial site).
• People who need blood-thinning or anti-clotting medications, such as warfarin, certain Factor Xa inhibitors, or anti-platelet drugs like clopidogrel.
• People whose heart electrical activity measurement (called a QTcF interval, recorded on an ECG) is above a certain threshold — the specific limit differs for males and females and also depends on other heart measurements (confirm details with trial site).
• People with a known allergy to any ingredient in the study drug (GIGA-2339), a history of serious allergic reactions to any medication, multiple drug allergies, or any other allergy history that the trial doctor believes would make participation unsafe.
• People who have received, or will need to receive, certain live vaccines — such as measles, mumps, rubella, or chickenpox vaccines — within 4 weeks before or up to 3 months after receiving the study treatment.

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