Phase 3 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 70 years old (men or women)
• Men weighing at least 50 kg, or women weighing at least 45 kg, with a body mass index (BMI) between 18 and 35
• People who have been continuously taking one of the following hepatitis B antiviral medicines for more than one year, with no break longer than one month in the past year: entecavir, tenofovir disoproxil fumarate, emivirofavir, or propivirofavir — and who have been on the same one of these medicines without change for more than 3 months before screening
• People who test positive for HBeAg and have a detectable hepatitis B virus (HBV) level in the blood above a certain threshold, measured by a sensitive lab test
• People whose liver enzyme level (ALT) is no more than 5 times the upper limit of the normal range at the time of screening
• People who are able and willing to use effective contraception from the time of screening until 28 days after the study ends (applies to men with a partner who could become pregnant, and to women who could become pregnant)
• People who are willing and able to sign a consent form and follow the study requirements throughout the trial

Who may not be able to join:

• People who have a history of life-threatening severe allergic reactions (such as anaphylactic shock), or who the investigator suspects may be allergic to the ingredients in the study medicine
• People who have taken certain medicines that affect how the body processes drugs (called CYP3A4 inhibitors, inducers, or substrates) within 28 days before screening
• People who have used medicines that suppress or modify the immune system, or cancer-fighting drugs, within the past 6 months — or who have received interferon treatment within the past 12 months — or who have received a live attenuated vaccine within the past month
• People who have an active infection requiring treatment at the time of joining the study
• People who have a significant liver disease caused by something other than hepatitis B, which the investigator determines makes them unsuitable for the trial
• People who have a history of cirrhosis (scarring of the liver), confirmed by a biopsy or by findings such as enlarged veins in the oesophagus or stomach on endoscopy; or people currently showing signs of advanced liver disease such as brain changes related to liver failure, kidney problems linked to liver disease, bleeding from oesophageal or stomach veins, an enlarged spleen, or fluid build-up in the abdomen; or people with significant worsening of liver scarring
• People with liver cancer, or certain elevated liver-related markers in the blood (AFP greater than 20 μg/L or DCP greater than 40 mAU/mL), or imaging results suggesting possible cancer in the liver; or people with another type of cancer currently or within the past 5 years (except for certain fully treated skin cancers or cervical carcinoma in situ)
• People with stomach or digestive conditions that may affect how oral medication is absorbed, such as serious stomach ulcers, gastritis, partial removal of the stomach, or significant nausea, vomiting, or diarrhoea at the time of screening
• People with serious conditions affecting the heart, lungs, kidneys, blood, immune system, mental health, nervous system, or other major body systems, which the investigator determines makes participation unsuitable
• People who have had major injury or major surgery within 3 months before screening, or who plan to have surgery during the study period
• People whose blood test results fall outside certain ranges, including: low platelet count, low white blood cell count, low neutrophil count (a type of white blood cell), high bilirubin levels, low albumin (a blood protein), reduced kidney function, or abnormal blood clotting results (confirm specific numbers with the trial site)
• People who test positive for hepatitis C, HIV, or active syphilis
• People with a history of heavy ongoing alcohol use in the past 3 years, defined as more than 14 units of alcohol per week (where one unit equals one 350 mL bottle of beer, 120 mL of wine, or 30 mL of spirits)
• People with a history of drug dependence or substance abuse
• People who have taken part in another clinical trial involving an experimental drug or medical device within 3 months before screening
• Women who are breastfeeding or who test positive for pregnancy
• People whom the investigator determines are unsuitable for any other reason (confirm with trial site)

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