[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepatitis-b-related-liver-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepatitis-b-related-liver-fibrosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100625047","phase-2-a-study-of-hydronidone-capsules-in-patients-with-chronic-hepatitis-b-virus-related-liver-fibrosis-100625047",false,"NCT07417553","A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis","A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis","Inclusion Criteria:\n\n* Age 18 to 70 years (inclusive of 18 and 70 years old, based on the date of signing the informed consent form), regardless of gender.\n* History of chronic hepatitis B and\u002For Hepatitis B surface antigen (HBsAg) positive for ≥6 months.\n* Diagnosed with chronic hepatitis B-related fibrosis by the investigator, meeting any of the following criteria:\n\n  1. Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score ≥F2;\n  2. Liver stiffness measurement (Fibroscan, Fibrotouch, or ILivTouch; results from within 1 month prior to screening are acceptable) with a liver stiffness value ≥9.0 kPa;\n  3. Imaging examination (results from within 12 months prior to screening are acceptable), such as abdominal ultrasound, CT, or MRI, indicating morphological features of cirrhosis (e.g., irregular liver surface, liver lobe disproportion, etc.).\n* Currently receiving stable antiviral therapy with one or two drugs such as ETV (Entecavir), TAF (Tenofovir Alafenamide), TDF (Tenofovir Disoproxil Fumarate), or TMF (Tenofovir Mefenamide) for ≥6 months.\n* The study participant agrees, from the time of signing the informed consent form until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, with no plans for pregnancy, sperm donation, or egg donation during this period.\n* Prior to the trial, the participant has fully understood the nature, significance, potential benefits, possible inconveniences, and risks of the study, voluntarily agrees to participate in this clinical trial, can communicate well with the investigator, adheres to all study requirements, and has signed a written informed consent form.\n\nExclusion Criteria:\n\n* Individuals with a history of specific allergies (e.g., asthma, urticaria, eczema), an allergic constitution (e.g., allergy to drugs or food), or known allergy to Hydroxynidone, pirfenidone, any of their components, or excipients.\n* Individuals currently suffering from the following serious concurrent diseases:\n\n  1. Cardiovascular System: Uncontrolled heart failure (NYHA Class III-IV), unstable angina, myocardial infarction within the past 6 months, uncontrolled hypertension, etc.\n  2. Renal Diseases: Severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²), end-stage renal disease, acute kidney injury, etc.\n  3. Endocrine and Metabolic Diseases: Poorly controlled diabetes (HbA1c \\>8.5%), thyroid crisis, etc.\n  4. Other Chronic Liver Diseases: Alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or severe hepatic steatosis (CAP ≥295 dB\u002Fm).\n  5. Individuals currently receiving anti-tuberculosis treatment or diagnosed with active tuberculosis.\n* Individuals with a history of decompensated liver cirrhosis (e.g., ascites, hepatic encephalopathy, history of esophageal and gastric variceal bleeding) within 12 months prior to screening, patients with clinically diagnosed liver malignancy, or those with other confirmed malignancies.\n* Individuals with a history of major upper gastrointestinal bleeding within 6 months prior to screening; those scheduled or requiring immediate upper gastrointestinal endoscopy (gastroscopy) during the trial due to portal hypertension; or cACLD patients with liver stiffness measurement ≥20 kPa and\u002For platelet count ≤150×10⁹\u002FL.\n* Individuals with abnormal laboratory test results or clinically significant abnormalities as judged by the investigator:\n\nTotal bilirubin (TBIL) \\>3 × ULN, or 3 × ULN \\\u003C ALT \\\u003C8 × ULN and TBIL \\>2 × ULN.\n\nALT ≥8 × ULN.\n\nPlatelet count (PLT) ≤50 × 10⁹\u002FL.\n\nProthrombin activity (PTA) \\\u003C40% or International Normalized Ratio (INR) \\>1.5.\n\n* Individuals with a body mass index (BMI) \\>32 kg\u002Fm².\n* Individuals with alpha-fetoprotein (AFP) \\>100 μg\u002FL in the absence of indicators suggesting hepatocellular carcinoma.\n* Concurrent users of the following medications:\n\n  1. Currently using interferon.\n  2. Use of known CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) or inducers (e.g., rifampicin, omeprazole) prior to screening, with a washout period less than 7 half-lives of the respective drug.\n  3. Use of complex traditional Chinese herbal formulations, herbal medicines, or health supplements with unclear interaction profiles.\n* Individuals with a history of or currently suffering from severe depression, post-traumatic stress disorder (PTSD), other serious mental disorders (e.g., schizophrenia, bipolar disorder, etc.), or cognitive impairment, who are unable to cooperate with medication administration and follow-up.\n* Individuals with dysphagia, swallowing disorders, or diseases affecting digestion and absorption, such as inflammatory bowel disease, short bowel syndrome, etc.\n* Individuals testing positive for human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus (HCV) antibody.\n* Individuals with a history of drug abuse, alcohol abuse, or drug dependence (including methadone maintenance therapy) within 12 months prior to screening.\n* Pregnant or lactating women.\n* Individuals who do not agree, from the time of signing the informed consent until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, and have no plans for pregnancy, sperm donation, or egg donation during this period.\n* Individuals who have participated in other clinical trials and used investigational drugs or medical devices within 3 months prior to screening.\n* Individuals unable to complete the trial for other reasons, or those deemed unsuitable for participation by the investigator due to other factors.","ALL","18 Years","70 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion\u002Fexclusion criteria will receive Hydronidone treatment for 4 weeks. The study includes a screening period (up to 21 days) to assess the eligibility of participants. Eligible participants will enter the treatment period and receive Hydronidone capsules at a dosage of 270 mg TID (30 mg\u002Fcapsule, 3 capsules each time, three times daily, taken orally half an hour before meals) for 28 consecutive days. Participants will return for a follow-up visit on Day 28 (±3 days) after the first dose for safety assessments. All adverse events (AEs) and concomitant medications occurring during the study period must be recorded. After the treatment period, participants will enter a follow-up period to monitor any delayed adverse events. Participants who complete the final follow-up visit are considered to have completed the study. Throughout the study, participants must maintain the stability of all their pre-existing treatment regimens, including antiviral therapy and medications for other comorbid conditions.",[27],"Chronic Hepatitis B-related Liver Fibrosis",[29],"Chronic Hepatitis B-related liver fibrosis","RECRUITING","2026-04-21",{"date":33,"type":34},"2026-04-24","ACTUAL",{"date":36,"type":34},"2026-04-14",{"date":38,"type":21},"2026-07-30",{"name":40,"class":41},"Beijing Continent Pharmaceutical Co, Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":42},"100629172","phase-1-c-hydronidone-mass-balance-study-100629172","NCT07471217","[¹⁴C] Hydronidone Mass Balance Study","[¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants","Inclusion Criteria:\n\n* Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;\n* Chinese adult male participants aged 18 to 50 years (inclusive);\n* Participants weighing at least 50 kg at screening, with a body mass index \\[BMI = weight (kg) \u002F height² (m²)\\] within the range of 19.0 to 26.0 kg\u002Fm² (inclusive);\n* Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.\n\nExclusion Criteria:\n\n* The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;\n* Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;\n* Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;\n* Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen\u002Fantibody;\n* Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period;\n* A previous diagnosis of Gilbert's syndrome;\n* Hemorrhoids with bloody stools or perianal diseases with regular or ongoing bloody stools; severe nausea or vomiting within one week before screening; habitual constipation or diarrhea; or positive fecal occult blood test;\n* Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days or 5 half-lives (whichever is longer) prior to dosing; use of strong inhibitors or inducers of UGTs, SULTs, CYP3A4, P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1\u002F3, or any drugs known to prolong the QT\u002FQTc interval or carry a risk of causing torsade de pointes (TdP) within 4 weeks before screening (see Appendix 2 for details); or plans to use any chemical drugs, biologics, traditional Chinese medicines, or natural products during the trial that the researcher deems unsuitable;\n* A history of drug allergies or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a suspected or confirmed allergy to the trial drug (including similar drugs) or any of its excipients as determined by the researcher;\n* Participants with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;\n* Participation in any other clinical trial drug or interventional clinical study within 3 months before screening;\n* Blood donation or blood loss ≥ 400 mL within 3 months before dosing, or blood transfusion or use of blood products within 4 weeks before dosing;\n* Difficulty in blood collection or intolerance to venous blood sampling.\n* Individuals who work with long-term exposure to radioactive conditions, or those with significant radioactive exposure within 1 year prior to screening (≥2 chest\u002Fabdominal CT scans, or ≥3 other types of X-ray examinations), or those who have participated in radiolabeled drug trials within 1 year prior to screening;\n* History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine);\n* Average weekly alcohol consumption of ≥14 units within 3 months prior to screening (1 unit ≈ 360 mL beer, or 45 mL liquor, or 150 mL wine), or positive breath alcohol test;\n* Average daily smoking of \\>5 cigarettes (or equivalent nicotine products) within 3 months prior to dosing, or inability to discontinue any tobacco products during the study, or positive cotinine test;\n* Habitual consumption of grapefruit juice or excessive tea, coffee, and\u002For caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL), and inability to abstain during the study; or consumption of any chocolate, caffeine, or xanthine-rich foods or beverages within 48 hours prior to dosing;\n* Vaccination within 4 weeks prior to dosing, or planned vaccination within 1 month after dosing;\n* Other reasons deemed by the investigator as making the participant unsuitable for this study.",true,"MALE","50 Years",{"count":54,"type":21},8,[56],"PHASE1","According to the \"Technical Guidelines for Radioactive Labeled Human Mass Balance Studies\" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a \\[¹⁴C\\] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.",[27],[29,60],"Hydronidone","NOT_YET_RECRUITING","2026-03-10",{"date":64,"type":34},"2026-03-13",{"date":66,"type":21},"2026-04-30",{"date":38,"type":21},{"name":40,"class":41}]