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 70 years old (inclusive), of any gender, based on their age at the time of signing the consent form.
• People who have had chronic hepatitis B for 6 months or longer, or who have tested positive for the hepatitis B surface antigen (HBsAg) for at least 6 months.
• People diagnosed by a doctor with liver scarring (fibrosis) related to chronic hepatitis B, confirmed by at least one of: a liver biopsy within the past 12 months showing a certain level of scarring (Ishak score ≥3 or Metavir score ≥F2); a liver stiffness scan within the past month showing a reading of 9.0 kPa or higher; or imaging (ultrasound, CT, or MRI) within the past 12 months showing signs of liver cirrhosis.
• People who have been taking stable antiviral medication for hepatitis B — specifically one or two of the drugs Entecavir, Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Tenofovir Mefenamide — for at least 6 months continuously.
• People who agree to use effective contraception from the time of signing consent until 6 months after the last dose of the study drug, and who have no plans for pregnancy, sperm donation, or egg donation during that period.
• People who have been fully informed about the trial, understand what is involved including the risks and benefits, are willing to follow all study requirements, can communicate clearly with the research team, and have signed a written consent form.

Who may not be able to join:

• People with a history of serious allergies (such as asthma, hives, or eczema), a tendency toward allergic reactions to foods or medicines, or a known allergy to Hydroxynidone, pirfenidone, or any of their ingredients.
• People currently living with serious ongoing health conditions, including: uncontrolled or severe heart failure, unstable chest pain, a heart attack within the past 6 months, or uncontrolled high blood pressure; severely reduced kidney function or kidney failure; poorly controlled diabetes (HbA1c above 8.5%) or a thyroid crisis; other chronic liver conditions such as alcohol-related liver disease, drug-related liver injury, autoimmune liver disease, or severe fatty liver disease; or people currently receiving treatment for tuberculosis or diagnosed with active tuberculosis.
• People who have had serious complications of liver cirrhosis in the past 12 months — such as fluid build-up in the abdomen, confusion caused by liver failure, or bleeding from veins in the food pipe or stomach — or people diagnosed with liver cancer or any other confirmed cancer.
• People who have had a major bleed in the upper digestive tract within the past 6 months; people who need an urgent stomach scope procedure due to high blood pressure in the liver veins during the trial; or people with advanced liver scarring showing a liver stiffness reading of 20 kPa or more and/or a low platelet count of 150×10⁹/L or below.
• People with certain abnormal blood test results, including: total bilirubin (a measure of liver function) more than 3 times the upper normal limit under certain conditions; liver enzyme (ALT) levels 8 or more times the upper normal limit; a platelet count of 50×10⁹/L or below; or blood clotting results outside the accepted range (prothrombin activity below 40% or INR above 1.5).
• People with a body mass index (BMI) above 32 kg/m².
• People with an elevated alpha-fetoprotein (AFP) blood level above 100 μg/L when there are no other signs pointing to liver cancer (confirm with trial site).
• People currently using interferon; people who have recently used certain medications that affect how drugs are broken down in the body (specific CYP1A2 inhibitors or inducers) without enough time having passed since stopping them (confirm washout period with trial site); or people using complex herbal medicines or health supplements with unclear drug interaction profiles.
• People with a current or past history of severe depression, post-traumatic stress disorder (PTSD), serious mental health conditions (such as schizophrenia or bipolar disorder), or cognitive impairment that would make it difficult to take medications correctly or attend follow-up appointments.
• People who have difficulty swallowing, swallowing disorders, or conditions that affect digestion and absorption, such as inflammatory bowel disease or short bowel syndrome.
• People who test positive for HIV, syphilis (Treponema pallidum), or hepatitis C (HCV).
• People with a history of drug abuse, alcohol abuse, or drug dependence (including methadone treatment) within the 12 months before screening.
• Women who are pregnant or breastfeeding.
• People who do not agree to use effective contraception for themselves and their partner from the time of signing consent until 6 months after the last dose, or who plan to become pregnant or donate sperm or eggs during that period.
• People who have taken part in another clinical trial or used an experimental drug or medical device within the 3 months before screening.
• People who, for any other reason, are considered by the investigator to be unsuitable for the trial, or who are unlikely to be able to complete it.

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