[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Livzon Pharmaceutical Group Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100590123","phase-2-phase-ii-clinical-study-of-h001-capsule-in-the-prevention-of-venous-thromboembolism-after-total-knee-arthroplasty-100590123",false,"NCT06963320","Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty","A Multicenter, Randomized, Open-label, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of H001 Capsules in the Prevention of Venous Thromboembolism (VTE) in Subjects Undergoing Total Knee Arthroplasty","Inclusion Criteria:\n\n1. Patients scheduled to undergo elective primary unilateral total knee arthroplasty (TKA);\n2. Aged 18-74 years (inclusive) on the day of signing the informed consent form, regardless of gender;\n3. Willing and able to voluntarily sign the informed consent form and comply with the study protocol;\n4. Women of childbearing potential or subjects whose partners are women of childbearing potential must agree to use effective contraception throughout the study period. Acceptable methods include oral, implantable, or injectable hormonal contraceptives; mechanical products (e.g., intrauterine devices, diaphragms, condoms, spermicides); abstinence; or confirmed sterilization (e.g., vasectomy, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding female subjects;\n2. Body weight \\\u003C40 kg at screening;\n3. History of allergy to contrast agents or inability to undergo bilateral lower limb venography; history of hypersensitivity to the study drug or drugs of the same class; known allergy to enoxaparin or any component listed in the enoxaparin prescribing information;\n4. High bleeding risk or contraindications to enoxaparin (e.g., known or suspected heparin-induced thrombocytopenia, severe hematologic disorders, severe coagulation abnormalities);\n5. History of deep vein thrombosis (DVT) or DVT confirmed during screening;\n6. Clinically significant medical history, including\n\n   1. Hemorrhagic stroke or intracranial conditions (e.g., hemorrhage, tumor, arteriovenous malformation, or aneurysm);\n   2. Recurrent upper gastrointestinal or genital\u002Furinary tract ulcers\u002Fbleeding, intraocular bleeding, or clinical bleeding within 6 months prior to screening (as judged by the investigator to increase bleeding risk);\n   3. Acute hepatitis within 1 year prior to screening or persistent severe liver disease (e.g., chronic active hepatitis, cirrhosis, or chronic hepatic insufficiency);\n   4. Myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism, or coronary revascularization within 6 months prior to screening; transient ischemic attack or ischemic stroke;\n   5. Chronic congestive heart failure with NYHA Class IV cardiac function;\n   6. Severe arrhythmias requiring Class Ia or III antiarrhythmic drugs; sinus node dysfunction, Type II Mobitz or third-degree atrioventricular block without pacemaker implantation;\n   7. History of QTc interval prolongation or QTc interval ≥480 ms during screening;\n7. Poorly controlled hypertension within 3 months prior to screening (defined as failure to achieve target blood pressure despite ≥3 antihypertensive medications) or systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg confirmed during screening;\n8. Major surgery or trauma within 3 months prior to screening, particularly involving the brain, spine, or eyes;\n9. Use of the following treatments:\n\n   1. Ongoing or recent (within 7 days pre-surgery) anticoagulant therapy (e.g., after mechanical heart valve replacement) or plans to continue such therapy during the study;\n   2. Oral antiplatelet therapy (e.g., aspirin \\>165 mg\u002Fday, clopidogrel, ticlopidine, dipyridamole) within 7 days pre-surgery or plans to continue during the study;\n   3. Long-acting NSAIDs within 7 days or 5 half-lives (whichever is longer) prior to surgery;\n   4. Thrombolytic therapy for ischemic disease within 6 months prior to screening;\n10. Planned or ongoing use of epidural analgesia post-surgery; planned or ongoing use of intermittent pneumatic compression devices, electrical\u002Fmechanical muscle stimulators post-surgery; intraoperative complications (e.g., hemorrhage or severe trauma) during spinal\u002Fepidural anesthesia;\n11. Laboratory abnormalities at screening:\n\n    1. Total bilirubin \\>1.5×ULN, ALT or AST \\>3×ULN;\n    2. Serum creatinine \\>1.5×ULN; chronic kidney disease with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n    3. Hemoglobin \\\u003C100 g\u002FL;\n    4. Platelet count \\\u003C100×10⁹\u002FL;\n    5. APTT, PT, or INR \\>ULN with clinical significance (investigator judgment);\n12. History of malignancy within 5 years prior to screening (excluding basal cell carcinoma or Stage I squamous cell carcinoma);\n13. Positive serum pregnancy test (hCG) during screening;\n14. Participation in another drug\u002Fdevice clinical trial within 1 month prior to screening or within 5 half-lives of the investigational drug (whichever is longer);\n15. History of drug abuse or psychiatric disorders;\n16. Other conditions deemed unsuitable for study participation by the investigator.","ALL","18 Years","74 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a multicenter, randomized, open-label, positive-controlled Phase II clinical study to evaluate the efficacy and safety of H001 capsules in the prevention of venous thromboembolism (VTE) in subjects undergoing Total Knee Arthroplasty.",[27],"Circulatory Disease","RECRUITING","2025-04-30",{"date":31,"type":32},"2025-05-09","ACTUAL",{"date":34,"type":32},"2025-01-20",{"date":36,"type":21},"2025-07-30",{"name":38,"class":39},"Livzon Pharmaceutical Group Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":40},"100581451","phase-3-a-phase-iii-clinical-trial-for-efficacy-and-safety-evaluation-of-jp-1366-tablets-on-reflux-esophagitis-100581451","NCT06850480","A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis","A Multicenter, Randomized, Double-blind, Double-simulated, Positive Parallel-control Phase III Clinical Trails of JP-1366（Zastaprazan Citrate） Tablets and Nexium® on Reflux Esophagitis","Inclusion Criteria:\n\n1. Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;\n2. Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.\n3. Those who have experienced heartburn and reflux symptoms (with medical records) within 7 days before screening or who have been diagnosed with reflux esophagitis by endoscopic examination within 7 days before screening;\n4. Screening period for upper gastrointestinal endoscopy, diagnosed with grade A-D reflux esophagitis in Los Angeles (those who have received endoscopic examination results from our center, have been judged by researchers to meet the diagnostic criteria, and have not been examined within 14 days before randomization, do not need to repeat this examination).\n5. LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage \\> 4%;\n6. Women of childbearing age or significant other male subjects of childbearing age are willing to use effective contraceptive measures throughout the study period, such as oral, implanted, or injected contraceptive hormones, or use mechanical products such as intrauterine devices or barrier methods (uterine caps, , spermicides), or practice abstinence or self\u002Fsignificant other sterilization (such as vasectomy, hysterectomy, bilateral salpinectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n1. Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;\n2. Those who cannot accept upper gastrointestinal endoscopy;\n3. Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;\n4. History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;\n5. Screening for patients with active peptic ulcers and active upper\u002Flower gastrointestinal bleeding within the first 3 months; or patients with a history of active peptic ulcers and active upper\u002Flower gastrointestinal bleeding more than 3 months after screening, and those who did not recover after endoscopic examination of the upper gastrointestinal tract during the screening period;\n6. Patients with concomitant diseases that may affect esophageal motility (such as scleroderma, viral infection or fungal infection, etc.), or those with a history of esophageal radiotherapy or cryotherapy;\n7. Have undergone surgery to reduce gastric acid secretion, or any surgery that affects the structure or function of the esophagus, stomach, or duodenum (except for benign tumor resection, benign polyp endoscopic resection, simple suture surgery such as gastric perforation);\n8. Subjects with warning symptoms of upper gastrointestinal malignancies or gastrointestinal malignancies (such as swallowing pain, severe dysphagia, bleeding, weight loss, anemia, hemoptysis or hematochezia) (except for those with negative endoscopic malignancies);\n9. People with a history of the following clinically significant diseases:\n\nThose with a history of hemorrhagic stroke or any of the following intracranial diseases (bleeding, tumors, arteriovenous malformations (AVMs), or aneurysms); There are recurrent upper gastrointestinal or gastrointestinal ulcers\u002Fbleeding, and researchers believe that there is an increased risk of bleeding or clinical bleeding has occurred within the past 6 months before screening.\n\nThose who have had acute clinical hepatitis or a history of major liver disease (active phase of chronic hepatitis, cirrhosis, or chronic liver dysfunction) within the past year before screening.\n\nScreening for those who have had myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within the past 6 months; those who have undergone coronary artery revascularization within 6 months; transient ischemic attack or ischemic stroke.\n\nPatients with a history of chronic congestive heart failure and NYHA IV heart function.\n\nThere are severe arrhythmias that require treatment with Class Ia or III antiarrhythmic drugs; arrhythmias with diseased sinus syndrome, Class II or III atrioventricular block, and pacemakers have not yet been implanted.\n\nPeople with a history of prolonged QTc interval or screening period with QTc interval ≥ 480ms (according to Fridericia correction formula, where QTc = QT\u002FRR \\^ 0.33).\n\nSubjects with any history of active malignant tumors within the first 5 years of screening (excluding cured basal cell carcinoma, papillary thyroid carcinoma, and radical resection of carcinoma in situ such as intraductal carcinoma of the and cervical carcinoma in situ).\n\nSubjects who need to continue receiving non-steroidal anti-inflammatory drugs (such as aspirin), systemic corticosteroids, or antithrombotic drugs during the trial period (excluding those who use prophylactic low-dose aspirin (≤ 100mg\u002Fday)).\n\n12\\. Subjects who have taken gastric acid inhibitors (e.g. P-CAB, PPI) within 2 weeks before the first dose; or subjects who have taken H2 receptor blockers within 1 week before the first dose; 13. Subjects who were using retroviral antiviral drugs such as azanavir and nefinavir at the time of screening; 14. Those who meet any of the following requirements during the screening: Serum creatinine \\> 1.5 × ULN; history of chronic kidney disease, estimated glomerular filtration rate (eGFR) \\\u003C 30ml\u002Fmin\u002F1.73m2.\n\nTotal bilirubin \\> 1.5 × ULN, alanine aminotransferase (AST)\u002Faspartate aminotransferase (ALT) \\> 3 × ULN.\n\n15\\. Have participated in any systemic therapeutic drug clinical trial (defined as administered) within the first 3 months of screening or within 5 half-lives of the test drug (whichever is longer); 16. Pregnant or lactating women; 17. The investigator determines that the subjects are not suitable to participate in this experiment.","75 Years",{"count":50,"type":21},356,[52],"PHASE3","To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.",[55],"Reflux Esophagitis (RE)","2025-02-21",{"date":58,"type":32},"2025-02-27",{"date":60,"type":32},"2024-12-05",{"date":29,"type":21},{"name":38,"class":39},""]