Phase 1 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:

• You have been confirmed to have HDV (Hepatitis Delta Virus) infection through blood tests showing both HDV antibodies and detectable HDV in your blood
• You do not have Hepatitis B surface antibodies showing up in recent blood tests
• Both people who test positive and negative for a specific Hepatitis B marker (HBeAg) are welcome to apply
• You are able and willing to give your formal agreement to take part in the study
• If you can become pregnant, you must agree to use two methods of contraception during the study
• If you can get someone else pregnant and are sexually active in a way that could lead to pregnancy, you must agree to use condoms starting 10 days before joining the study and throughout the follow-up period

Who may not be able to join:

• Your liver disease has been scored above 9 points on a standard liver health scale called the Child-Turcotte-Pugh scale
• You are currently experiencing, or have experienced in the last 12 months, serious liver complications such as brain problems caused by liver failure (hepatic encephalopathy) or serious internal bleeding from the digestive system (variceal hemorrhage)
• You have had a confirmed serious allergic reaction (such as hives or a life-threatening allergic response) to a monoclonal antibody or vaccine, or you have allergies to multiple medicines (mild hay fever that is not currently active is acceptable)
• You are currently pregnant or breastfeeding
• You have received any vaccine in the 2 weeks before joining the study
• You have previously received a specific treatment called HepB mAb19
• You have had a significant infection (such as flu or COVID-19) or any other notable illness in the 2 weeks before joining
• You currently have an active Hepatitis C infection
• You have HIV that is not being treated
• You have HIV and are on treatment, but your HIV viral load has been above 50 copies/mL more than once in the past 6 months (a single reading between 50 and 500 copies/mL during that period may still be acceptable — confirm with trial site)
• You are currently taking part in another clinical trial of an experimental treatment, have done so in the past 12 weeks, or expect to do so during this study
• Your blood test shows a protein called alpha fetoprotein above 100 ng/mL (a marker sometimes linked to liver problems)
• Your blood test shows your red blood cell levels (hemoglobin) are too low — below 10 g/dL
• Your platelet count (cells that help blood clot) is too low — below 25,000 per mm³
• Your kidney filtering function (eGFR) is below 60 mL/min, suggesting reduced kidney function
• A liver enzyme in your blood called ALT is more than 10 times the normal upper limit
• You have or have had a significant heart condition, such as heart failure, coronary artery disease, or cardiomyopathy
• You have certain abnormal heart rhythm readings on an ECG (heart tracing) that fall outside acceptable ranges (confirm with trial site)
• You have another chronic liver disease, an inflammatory bowel condition, or an autoimmune disease that the study doctor feels would make participation unsafe (confirm with trial site)
• You have previously had a stem cell transplant or a solid organ transplant (such as a kidney or liver transplant)

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