[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492246":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":163,"collaborators":26,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":26,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":26,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Beijing Continent Pharmaceutical Co, Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"F573 for injection groups","EXPERIMENTAL","The first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg\u002Fkg, and the subsequent 9 patients with CHB were given doses of 2.0 mg\u002Fkg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit.\n\nThe second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg\u002Fkg and 2.0 mg\u002Fkg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit.\n\nThe third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest",[13],"Drug: F573 for injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator","PLACEBO_COMPARATOR","1. The first stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 7 days.\n\n   Basic treatment: enteric-coated diammonium glycyrrhizinate capsules were administered at a dose of 150 mg 3 times a day.\n2. The second stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 14 days.\n\n   Basic treatment: Polyene phosphatidylcholines and glutathione drugs (no restricted dosage forms) are accepted as basic treatment.\n3. The third stage: the Screen eligible subjects were treated with Sterilizing water for injection. The dose volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days. Basic treatment: receive acetylcysteine injection at a dose of 8 g \u002F d once a day.",[19],"Drug: Sterilizing water for injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","F573 for injection","The first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg\u002Fkg, and the subsequent 9 patients with CHB were given doses of 2.0 mg\u002Fkg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit.\n\nThe second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg\u002Fkg and 2.0 mg\u002Fkg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit.\n\nThe third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest .",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sterilizing water for injection","The composition of this product is water for injection, and the dosage volume is 2mL for intramuscular injection.\n\nMedication course: The first stages were administered once a day for 7 days and second stages were administered once a day for 14 days. The third stage was administered once a day for 28 days.",[15],[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"ling zhang, Dr","CONTACT","13501209210","+86","zhangling@bjcontinent.com",{"name":39,"role":34,"phone":26,"phoneExt":26,"email":26},"junqi niu, Dr",[41,57,69,81,93,105,116,128,139,151],{"facility":42,"status":43,"city":44,"state":45,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Beijing You 'an Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":26,"phoneExt":26,"email":26},"Yu Cheng",{"facility":58,"status":43,"city":59,"state":60,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Qingyuan People's Hospital (Sixth Affiliated Hospital of Guangzhou Medical University)","Qingyuan","Guangdong",{"type":49,"coordinates":62},[63,64],113.03333,23.7,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":26,"phoneExt":26,"email":26},"bei zhong",{"facility":70,"status":43,"city":71,"state":72,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Shiyan City Taihe Hospital","Shiyan","Hubei",{"type":49,"coordinates":74},[75,76],110.77806,32.6475,{"lat":76,"lon":75},[79],{"name":80,"role":34,"phone":26,"phoneExt":26,"email":26},"zhongji meng",{"facility":82,"status":43,"city":83,"state":84,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hunan Medical College General Hospital (formerly Huaihua City First People's Hospital)","Huaihua","Hunan",{"type":49,"coordinates":86},[87,88],110.00404,27.56337,{"lat":88,"lon":87},[91],{"name":92,"role":34,"phone":26,"phoneExt":26,"email":26},"yongzhong Li",{"facility":94,"status":43,"city":95,"state":96,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Pingxiang Second People's Hospital","Pingxiang","Jiangxi P",{"type":49,"coordinates":98},[99,100],113.85353,27.61672,{"lat":100,"lon":99},[103],{"name":104,"role":34,"phone":26,"phoneExt":26,"email":26},"shuqiang ou",{"facility":106,"status":43,"city":107,"state":108,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"First Hospital of Jilin University","Changchun","Jilin",{"type":49,"coordinates":110},[111,112],125.32278,43.88,{"lat":112,"lon":111},[115],{"name":39,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":117,"status":43,"city":118,"state":119,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"The Affiliated Hospital of Binzhou Medical University","Binzhou","Shandong",{"type":49,"coordinates":121},[122,123],118.01667,37.36667,{"lat":123,"lon":122},[126],{"name":127,"role":34,"phone":26,"phoneExt":26,"email":26},"Chengxia liu",{"facility":129,"status":43,"city":130,"state":119,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Heze Municipal Hospital","Heze",{"type":49,"coordinates":132},[133,134],115.47358,35.23929,{"lat":134,"lon":133},[137],{"name":138,"role":34,"phone":26,"phoneExt":26,"email":26},"fangqi ge",{"facility":140,"status":43,"city":141,"state":142,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Shanxi Bethune Hospital","Taiyuan","Shanxi",{"type":49,"coordinates":144},[145,146],112.56028,37.86944,{"lat":146,"lon":145},[149],{"name":150,"role":34,"phone":26,"phoneExt":26,"email":26},"Jia \u002F Yan Yao \u002F Wang",{"facility":152,"status":43,"city":153,"state":154,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Affiliated Hospital of Southwest Medical University","Luzhou","Sichuan",{"type":49,"coordinates":156},[157,158],105.42575,28.8903,{"lat":158,"lon":157},[161],{"name":162,"role":34,"phone":26,"phoneExt":26,"email":26},"mingming deng",{"type":164,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100492246","phase-2-f573-for-injection-for-the-treatment-of-liver-injuryfailure-100492246",false,"NCT05689645","F573 for Injection for the Treatment of Liver Injury\u002FFailure","F573 for Injection for the Treatment of Liver Injury\u002FFailure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial","Inclusion Criteria:\n\n（1）The first stage:\n\nParticipants who meet all of the following criteria will be enrolled in the study:\n\n1. Age ≥18 and ≤60 years old, gender is not limited;\n2. Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the \"Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)\"). Screening patients with CHB may provide etiological (HBsAg positive and\u002For HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.\n3. Serum ALT: 2\\~ 10× upper limit of normal (ULN), TBil: \\\u003C5×ULN;\n4. DILI patients: the abnormal duration of liver biochemical indexes \\[ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time\\] does not exceed 90 days;\n5. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;\n6. Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.\n\n(2)The second stage:\n\nSubjects meeting all of the following criteria will be included in the study:\n\n1. Age ≥ 18 and ≤ 65 years old, with no gender restrictions;\n2. According to the \"Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition)\", patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;\n\n   1. Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT \\> 3 times the upper limit of normal (ULN), and TBil \\> 2 times the ULN (the ULN of TBil refers to 17.1 μmol\u002FL according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;\n   2. Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil \\> 2 times the ULN (the ULN of TBil refers to 17.1 μmol\u002FL); ② ALP \\> 1.5 times the ULN; ③ALT\\>1×ULN;\n3. The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;\n4. They have signed the informed consent form and can comply with the requirements of the protocol; if the subjects are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required by the regulations.\n\nThe third stage:\n\nSubjects who meet all of the following criteria will be enrolled in the study:\n\n1\\. Age ≥18 and ≤70 years old, gender is not limited; 2. Patients diagnosed with chronic and acute liver failure with TBil≥5×ULN according to the \"Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)\" may have hepatic encephalopathy (Grade 1-2) or ascites (grade 1-2) 4 weeks before subject screening. And 5≤AARC score ≤10 (AARC rating I-II); 3. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration; 4. Sign informed consent and comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.\n\n\\-\n\nExclusion Criteria:\n\nThe first stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. According to the investigator's judgment, the subjects were patients with cholestatic liver injury;\n2. Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;\n3. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;\n4. There are the following laboratory test values or abnormal test values:\n\n   1. Blood routine: platelet (PLT) \\\u003C75× 109\u002FL, hemoglobin (HGB) \\\u003C90 g\u002FL;\n   2. Prothrombin activity \\\u003C40%, prothrombin time (PT) extended \\>5 s;\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n5. Allergic or intolerant to the investigational drug, or allergic;\n6. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n7. Poor compliance can not partner;\n8. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n9. Participants in other clinical trials within 3 months;\n10. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;\n11. The researcher considers any circumstances unsuitable for inclusion.\n\nThe second stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. The diagnosis is advanced liver cirrhosis (with complications such as ascites and hepatic encephalopathy), or liver cancer, or when liver stiffness measurement (LSM) is ≥ 18.0 kPa during screening.\n2. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases are malignantTumor patients;\n3. There are the following laboratory test values or abnormal test values:\n\n   1. Blood routine: platelet (PLT) \\\u003C100×109\u002FL, hemoglobin (HGB) \\\u003C100 g\u002FL;\n   2. INR\\>1.4, or as determined by the investigator to meet the criteria for severe hepatitis;\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n4. Allergic or intolerant to the investigational drug, or allergic;\n5. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n6. Poor compliance can not partner;\n7. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n8. Participants in other clinical trials within 3 months;\n9. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine and basic therapeutic drugs (polyene phosphatidylcholines and glutathione drugs) within 3 days before randomization;\n10. Patients who had used glucocorticoids or interferon drugs within 3 days before randomization;\n11. The researcher considers any circumstances unsuitable for inclusion.\n\nThe third stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. Patients who have completed liver transplantation or plan to undergo liver transplantation within 1 month;\n2. Severe grade 3 ascites or stubborn ascites;\n3. Patients with ≥ grade 3 hepatic encephalopathy;\n4. Patients who received artificial liver treatment within 1 week before screening;\n5. Patients with severe underlying diseases, such as respiratory system, digestive system, circulatory system, endocrine and other diseases and malignant tumors, and patients with severe infections that cannot be controlled by drugs;\n6. During the screening period or within 1 month before screening, the results of gastroscopy or imaging (abdominal B-ultrasound, CT or MRI) examination suggest severe varicose veins with bleeding risk;\n7. Patients with acute kidney injury (AKI), defined as meeting one of the following conditions:\n\n   1. Serum creatinine (Scr) increased ≥26.5 μmol\u002FL (0.3 mg\u002FdL, 1 mg\u002FdL=88.4 μmol\u002FL) within 48 h;\n   2. The Scr increase exceeds 1.5 times or more of the base value within 7 days;\n   3. Decreased urine volume (\\\u003C0.5 mL\u002Fkg\u002Fh) for more than 6 hours;\n8. Allergic or intolerant to the investigational drug, or allergic;\n9. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n10. Poor compliance can not partner; 11 Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n\n12\\. Participants in other clinical trials within 3 months; 13. The researcher considers any circumstances unsuitable for inclusion.","ALL","18 Years","60 Years",{"count":176,"type":177},97,"ESTIMATED","INTERVENTIONAL",[180],"PHASE2","This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .\n\nThe primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.).",[183,184],"Acute Liver Failure","Acute-On-Chronic Liver Failure",[186],"F573 for injection Liver Injury\u002FFailure","2025-11-17",{"date":189,"type":190},"2025-11-19","ACTUAL",{"date":192,"type":190},"2023-03-24",{"date":194,"type":177},"2026-09-01",{"name":5,"class":6},10]