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:

• Adults aged 18 to 65 years old who are able to give informed consent, follow study procedures, and agree to stop their hepatitis B antiviral tablet medication if certain conditions set out in the study protocol are met.
• People with a body mass index (a measure of body weight relative to height) of 35 or below.
• People who have had a confirmed chronic hepatitis B infection for at least 6 months before joining the study, shown by a positive hepatitis B surface antigen test or detectable hepatitis B virus in the blood.
• People who test negative for a specific hepatitis B marker called hepatitis B e antigen (HBeAg) at the screening visit.
• People who have been taking a single approved hepatitis B antiviral tablet medication (called a nucleos(t)ide analog) at a stable dose for at least 6 months before joining the study.
• People whose hepatitis B virus level in the blood is below the detectable threshold at screening.
• People whose hepatitis B surface antigen level in the blood falls within a specific range (greater than 100 and no more than 3,000 IU/mL) at screening.
• People whose liver enzyme level (ALT, a marker of liver health) is no more than twice the upper limit of the normal range at screening.
• People whose heart tracing (ECG) at screening shows no significant abnormalities and whose heart rhythm measurement falls within the acceptable range for their sex.
• Women who could become pregnant must not be breastfeeding and must have a negative pregnancy test at screening and before receiving the first dose.
• Men and women who could become pregnant must agree to use effective contraception methods specified in the study protocol during treatment and for at least 6 months after the last dose of the study drug AHB-137.

Who may not be able to join:

• People who have a significant medical condition other than chronic hepatitis B, including a recent heart attack (within the past 6 months), serious or unstable heart disease, uncontrolled diabetes, blood clotting problems, or a history of organ or bone marrow transplant.
• People who have another significant liver condition alongside hepatitis B, such as hepatitis caused by other viruses, inherited liver conditions, autoimmune liver disease, alcohol-related liver disease, or a history of serious liver failure (such as fluid buildup in the abdomen, confusion caused by liver failure, or bleeding from veins in the digestive tract).
• People who have had a serious infection (other than hepatitis B) in the month before joining, or who needed intravenous antibiotics or antiviral treatment for an infection.
• People with a history of an immune-related blood platelet disorder called immune thrombocytopenia.
• People who are currently suspected to have liver scarring (cirrhosis) or whose liver stiffness measurement is above 9 kPa on a specialised scan.
• People who have a history of liver cirrhosis confirmed by a liver biopsy or a liver stiffness measurement above 12 kPa on a specialised scan.
• People who have had, currently have, or are suspected of having liver cancer (hepatocellular carcinoma), or whose blood level of a liver cancer marker (AFP) is 20 ng/mL or above at screening.
• People who have a history of certain conditions outside the liver that can be associated with hepatitis B infection, including kidney disease, a type of blood vessel inflammation called polyarteritis nodosa, a protein disorder called cryoglobulinemia, or uncontrolled high blood pressure.
• People who have an active infection with HIV, hepatitis C, hepatitis D, or active syphilis (note: people with previous hepatitis C or D exposure but no active virus detected in blood tests may still be considered, confirm with trial site).
• People whose blood test results at screening fall outside acceptable ranges, including low protein levels, reduced kidney function, abnormal blood clotting, low platelet count, elevated bilirubin (a liver marker), significant amounts of protein in the urine on repeated testing, or certain abnormal immune markers that require further investigation (confirm with trial site).
• People who have a history of blood vessel inflammation (vasculitis), current signs or symptoms suggestive of vasculitis (such as a rash, skin ulcers, or unexplained blood in the urine), or a history of conditions associated with vasculitis such as lupus or rheumatoid arthritis.
• People who have had a cancer diagnosis in the 5 years before screening, except for certain treated skin cancers, or people currently being investigated for a possible cancer.
• People who have a known allergy or sensitivity to any ingredient in the study drug.
• People who have had major surgery or a serious injury in the 3 months before screening, or who have planned surgery during the study period (unless the trial's medical monitor confirms eligibility).
• People whose current alcohol or substance use, in the investigator's judgement, may affect their ability to participate safely and consistently in the study.
• Women who are pregnant, breastfeeding, planning to become pregnant during the study, or who are unwilling to avoid egg donation or IVF procedures during the study.
• People who have taken part in another clinical trial or received an experimental treatment within a recent period before this study (the exact timeframe depends on the previous treatment and will be assessed by the trial site).
• People who have previously been treated with a type of gene-silencing therapy called antisense oligonucleotides (ASOs) or siRNA-based therapies.
• People who have recently used certain immune-suppressing medications, steroid treatments (other than short-term or inhaled/topical use), interferon therapy, or certain vaccinations within specified timeframes before screening, or who are currently taking a hepatitis B treatment called bulevirtide.
• People who regularly use blood-thinning medications or antiplatelet drugs (with limited exceptions assessed by the investigator).
• People who, in the investigator's judgement, have any other condition or circumstance that would make participation in the study unsuitable.

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