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 to 65 years
• People who test positive for a specific hepatitis B surface protein (HBsAg) at a low level (below 2,000 IU/mL) at the time of screening
• People who test negative for hepatitis B e antigen, which is a marker related to how active the hepatitis B virus is
• People whose hepatitis B virus levels in the blood have been below 10,000 IU/mL on two separate tests, taken at least 24 weeks apart, with the most recent test done at screening
• People whose liver enzyme levels (ALT) are within an acceptable range — below 35 U/L for males or 25 U/L for females — confirmed on at least two tests taken at least 24 weeks apart, with the most recent at screening

Who may not be able to join:

• People who are pregnant or breastfeeding
• Women who are able to become pregnant and are unable or unwilling to use highly effective contraception during the study and for 24 weeks after the study medication ends
• Men who are able to father children and are unable or unwilling to use condoms consistently, in addition to their female partner using another form of contraception, during the study and for 24 weeks after the study medication ends — note that even men who have had a vasectomy would still need their female partner to use an additional contraceptive method
• People with a known allergy or medical reason not to take a type of drug called siRNA, oligonucleotide, GalNAc, or any interferon product
• People currently taking the medications theophylline (taken by mouth) or methadone
• People who have received any treatment for hepatitis B in the 24 weeks before joining the trial
• People who have previously been treated with a type of drug called siRNA
• People who are also infected with hepatitis D virus (HDV), detected by a specific blood test
• People who are also infected with hepatitis C virus (HCV), detected by specific blood tests
• People who are also infected with HIV, detected by a specific blood test
• People who have cirrhosis (scarring of the liver), either confirmed by a previous liver biopsy or indicated by a liver stiffness score above 13 kPa on a special scan
• People with signs of severe liver failure, such as abnormal levels of certain proteins and substances in the blood, or a history of fluid build-up in the abdomen, bleeding from swollen veins in the digestive tract, or confusion caused by liver problems
• People who have liver cancer, a suspicious mass on a liver scan, or a very high level of a liver cancer marker in the blood (alpha-fetoprotein above 500 ng/mL)
• People with other causes of liver disease, such as iron overload (hemochromatosis), Wilson's disease, alcohol-related liver disease, severe fatty liver, or a genetic condition called alpha-1-antitrypsin deficiency
• People who have had an organ transplant or bone marrow transplant
• People currently needing long-term use of steroid medication (more than 10 mg of prednisone daily) or certain immune-system drugs (such as monoclonal antibodies or interferon) within 3 months of screening
• People with significant other health conditions — such as heart failure, kidney failure, chronic pancreatitis, or poorly controlled diabetes (HbA1c above 8.5%) — that in the opinion of the study doctor may affect participation
• People with reduced kidney function, based on specific blood test results (confirm with trial site)
• People with a low platelet count in the blood (below 90,000 per mm³)
• People with low haemoglobin levels — below 12 g/dL for males or 11 g/dL for females
• People with a low white blood cell count (below 2,500 cells per mm³)
• People with a low level of a specific type of white blood cell called neutrophils (below 1,500 cells per mm³, or below 1,000 cells per mm³ for people of African descent if considered a normal variation — confirm with trial site)
• People with active alcohol or drug misuse, or mental health conditions such as major depression, schizophrenia, bipolar disorder, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the study doctor's opinion, may affect participation
• People who have been diagnosed with or treated for cancer in the past 3 years (except for certain minor skin cancers that have been fully treated)
• People with certain immune-related conditions (such as lupus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, or moderate-to-severe psoriasis), or with significant heart, lung, or brain conditions, eye disease related to blood vessel problems, uncontrolled thyroid disease, or uncontrolled seizures, as assessed by a study doctor
• People who have taken part in another clinical trial and received an experimental drug within 90 days before screening
• People currently using certain immune-suppressing or chemotherapy medications (except a short course of steroid medication lasting one week or less)
• People with other conditions that, in the opinion of the study team, would prevent them from being followed throughout the study
• People who are unable to understand the study or are unwilling to sign a written consent form

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