[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Third People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":202},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,72,93,115,138,161,183],{"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},"100585681","phase-3-a-pan-usr-tb-multi-center-trial-100585681",false,"NCT06905522","A PAN-USR TB Multi-Center Trial","A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial","Inclusion criteria:\n\n1. Age range from 18 to 65 years old, regardless of gender;\n2. Clinical symptoms and\u002For pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;\n3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not; Recommend using respiratory specimens for GeneXpert MTB\u002FRIF testing;\n4. Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;\n5. Willing to undergo HIV testing;\n6. Willing to preserve samples including DNA;\n7. For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female subjects without fertility must have records of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include condoms, intrauterine devices, cervical caps with spermicides, and diaphragm with spermicides.\n\nExclusion criteria:\n\n1. Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);\n2. Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \\[including moxifloxacin, sitagliptin\\], pyrazinamide);\n3. Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \\[including moxifloxacin, sitagliptin\\], pyrazinamide). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB\u002FXDR, dissolution curve method, phenotypic drug sensitivity, etc.);\n4. Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy\u002Fbronchial tuberculosis\u002Fmediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);\n5. Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;\n6. Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;\n7. Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;\n8. Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol;\n9. Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;\n10. HIV positive;\n11. Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;\n12. Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g\u002FL; (4) Platelet count ≤ 50 × 10\\^9\u002FL; (5) Blood potassium levels are ≥ 5.5 mmol\u002FL or ≤ 3.5 mmol\u002FL;\n13. ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;\n14. Women who are pregnant or breastfeeding;\n15. Weight \\\u003C30 kg, or ≥90 kg;\n16. The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;\n17. Other conditions deemed unsuitable for participation in the study by the research doctors.","ALL","18 Years","65 Years",{"count":20,"type":21},610,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases. PAN-TB is an innovative concept in TB treatment, aiming to develop a universal regimen effective for all forms of active TB, including both drug-susceptible and drug-resistant strains. The primary goal of the PAN-TB regimen is to simplify the treatment process, reduce costs, and improve treatment success rates. The ideal Target Regimen Profile (TRP) for PAN-TB includes superior efficacy compared to standard treatment for non-drug-resistant TB, a reduced treatment duration from the current 4-6 months to 2-3 months, and improved safety and tolerability. This project aims to explore a new ultra-short-course treatment regimen for both drug-sensitive (DS-TB) and drug-resistant TB (MDR\u002FRR-TB), which aligns with the latest trends in TB treatment both domestically and internationally. The regimen also has significant practical implications for enhancing treatment efficacy and reducing patient burden. Furthermore, the study will explore the identification of new biomarkers closely linked to treatment outcomes over the course of full-cycle therapy.",[27],"Pulmonary Tuberculosis","RECRUITING","2025-11-27",{"date":31,"type":32},"2025-12-01","ACTUAL",{"date":34,"type":32},"2025-06-18",{"date":36,"type":21},"2029-12",{"name":38,"class":39},"Shenzhen Third People's Hospital","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100602226","post-radical-treatment-antiviral-strategies-in-hbv-related-liver-cancer-impact-on-tumor-prognosis-100602226","NCT07120750","Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis","The Impact of Different Antiviral Strategies on Tumor Prognosis in Patients With HBV-related Liver Cancer After Radical Treatment: A Prospective, Open-label, Non-randomized Clinical Study","PRTRAS 001","Inclusion Criteria:\n\n* Age: Participants must be between 18 and 70 years of age.\n* HBsAg Positive: Participants must be positive for hepatitis B surface antigen (HBsAg).\n* Confirmed Hepatocellular Carcinoma (HCC): Participants must have a pathological confirmation of HCC via surgical resection or local ablation.\n* BCLC Staging: Participants must have a Barcelona Clinic Liver Cancer (BCLC) staging of 0 or A.\n* Liver Function: Participants must have normal or well-compensated liver function, classified as Child-Pugh A.\n* Expected Survival: Participants must have an expected survival of more than 3 months.\n* Informed Consent: Participants must sign an informed consent form and agree to comply with the study requirements. If a participant is unable to sign the consent form, a legal guardian or agent must do so.\n\nExclusion Criteria:\n\n* Prior Systemic Cancer Treatments: Participants who have received prior systemic cancer treatments such as liver transplantation, chemotherapy, targeted therapy, or biological therapy will be excluded.\n* Other Active Malignancies: Participants with a history or presence of other active malignancies, except for skin basal cell carcinoma or squamous cell carcinoma that has been cured, or cervical carcinoma in situ, will be excluded.\n* Allergies to Interferon: Participants who are allergic to interferon or any of its components, or whom the investigator deems unsuitable for interferon therapy, will be excluded.\n* Other Chronic Liver Diseases: Participants with other chronic liver diseases such as hepatitis A, C, D, or E virus infection, alcoholic liver disease, genetic metabolic liver disease, or drug-induced liver disease will be excluded.\n* Autoimmune Diseases:Participants with autoimmune diseases,including autoimmune liver disease and psoriasis, will be excluded.\n* Severe Liver Dysfunction: Participants with severe liver dysfunction or decompensated cirrhosis will be excluded.\n* Renal Impairment: Participants with serum creatinine levels exceeding 1.5 times the upper limit of normal will be excluded.\n* Severe Systemic Diseases:Participants with severe systemic diseases affecting the heart,lungs,kidneys,brain,or blood will be excluded.\n* Severe Neuropsychiatric Disorders:Participants with severe neuropsychiatric disorders such as epilepsy, depression, mania, or schizophrenia will be excluded.\n* Unstable Medical Conditions:Participants with unstable diabetes,hypertension,hyperthyroidism,or other endocrine diseases will be excluded.\n* Retinopathy:Participants with a history of severe retinopathy or other evidence of retinopathy will be excluded.\n* Substance Abuse:Participants with a history of drug abuse or alcoholism will be excluded.\n* Pregnancy or Breastfeeding:Pregnant or breastfeeding women, or women planning to become pregnant during the study period who are unwilling to use contraception, will be excluded.\n* Investigator's Judgment:Participants whom the investigator deems unsuitable for the study based on their current medical condition will be excluded.\n* Concurrent Participation in Other Trials:Participants who are concurrently involved in other clinical research trials will be excluded.","70 Years",{"count":51,"type":21},332,"OBSERVATIONAL","The goal of this clinical trial is to learn if peginterferon alfa-2b can reduce the recurrence of HBV-related liver cancer in patients who have undergone radical treatment. The study will also explore the potential benefits of peginterferon alfa-2b in achieving clinical cure and its impact on reducing liver cancer recurrence.\n\nThe trial is designed as a single-center, non-randomized, open-label study. Participants will be HBV-related liver cancer patients who have received radical treatment. The study will compare two groups: one receiving nucleos(t)ide analogues (NAs) alone and the other receiving NAs combined with peginterferon alfa-2b. The main question it aims to answer is:\n\nCan peginterferon alfa-2b lower the 3-year recurrence rate in HBV-related liver cancer patients after radical treatment?\n\nParticipants will undergo regular follow-ups, including imaging studies and blood tests, to monitor for cancer recurrence and assess the safety of the treatment.",[55,56],"Hepatocellular Carcinoma (HCC)","Chronic Hepatitis B",[58,59,60,61,62],"Hepatocellular carcinoma","Peginterferon alfa-2b","Nucleos(t)ide analogues","Post-radical treatment","Clinical cure","NOT_YET_RECRUITING","2025-08-11",{"date":66,"type":32},"2025-08-13",{"date":68,"type":21},"2025-09-01",{"date":70,"type":21},"2030-12-31",{"name":38,"class":39},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100598802","phase-3-ultra-short-regimen-for-elderly-ds-tb-100598802","NCT07076225","Ultra-Short Regimen for Elderly DS-TB","A Ultrashort Regimen for Drug-susceptible Pulmonary Tuberculosis in Elderly Patients: A Multicenter Randomized Controlled Trial","Elderly-USR","Inclusion criteria:\n\n1. Aged 65 years or older, regardless of gender\n2. Clinical symptoms and\u002For pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;\n3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, and susceptible to rifampicin; Recommend using respiratory specimens for GeneXpert MTB\u002FRIF testing;\n4. Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;\n5. Willing to undergo HIV testing;\n6. Willing to preserve samples including DNA;\n\nExclusion criteria:\n\n1. Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);\n2. Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc);\n3. Resistance to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB\u002FXDR, dissolution curve method, phenotypic drug sensitivity, etc.);\n4. Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy\u002Fbronchial tuberculosis\u002Fmediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);\n5. Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;\n6. Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;\n7. Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;\n8. Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol;\n9. Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;\n10. HIV positive;\n11. Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;\n12. Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g\u002FL; (4) Platelet count ≤ 50 × 10\\^9\u002FL; (5) Blood potassium levels are ≥ 5.5 mmol\u002FL or ≤ 3.5 mmol\u002FL;\n13. ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;\n14. Weight \\\u003C30 kg, or ≥90 kg;\n15. The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;\n16. Other conditions deemed unsuitable for participation in the study by the research doctors.",{"count":81,"type":21},300,[24],"Tuberculosis (TB) remains one of the leading global public health concerns and is among the top ten causes of death from a single infectious agent. China ranks third worldwide in total TB burden, with a substantial proportion of cases classified as drug-susceptible TB (DS-TB). Despite the availability of effective standard treatment regimens, the current 6-month therapy duration poses challenges in terms of patient adherence, resource allocation, and overall treatment success.\n\nIn recent years, ultrashort-course regimens for DS-TB have been proposed and evaluated in clinical studies, showing promising results in improving adherence, reducing treatment duration, and maintaining or even enhancing treatment efficacy. However, these regimens have primarily been studied in younger populations, with limited data available for elderly patients. Older adults often present with age-related physiological changes, multiple comorbidities, and an increased risk of adverse drug reactions, which may affect both the efficacy and safety of treatment.\n\nTherefore, this study aims to assess the therapeutic effectiveness and safety profile of a novel ultrashort-course regimen for drug-susceptible pulmonary TB specifically in patients aged 65 years and older.",[27],"2025-07-18",{"date":87,"type":32},"2025-07-22",{"date":89,"type":21},"2025-07-25",{"date":91,"type":21},"2030-07-31",{"name":38,"class":39},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100598449","phase-4-clinical-efficacy-of-pegylated-interferon-alpha-2b-combined-with-nucleostide-analogues-in-the-treatment-of-chronic-hepatitis-b-patients-100598449","NCT07071636","Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patients","A Prospective Study Evaluating Pegylated Interferon Alpha-2b and Nucleos(t)Ide Analogues in Treating Chronic Hepatitis B With or Without Metabolic Dysfunction-Associated Steatotic Liver Disease","Inclusion Criteria: Adults aged 18-65 years, regardless of gender; HBsAg-positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU\u002FmL; No restriction on HBV DNA quantification; ALT \\\u003C10×ULN (upper limit of normal, ≤400 IU\u002FL); No prior interferon therapy within the past 1 year; Signed informed consent form obtained; Exclusion of comorbid metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nMASLD meets at least one of the following five metabolic criteria:\n\nBMI ≥23 or waist circumference \\>94 cm (male)\u002F80 cm (female) Fasting plasma glucose ≥5.6 mmol\u002FL or 2-hour postprandial blood glucose ≥7.8 mmol\u002FL or HbA1c ≥5.7% or diagnosis of Type 2 Diabetes Mellitus or undergoing anti-diabetic therapy Blood pressure ≥130\u002F85 mmHg or receiving antihypertensive medication Plasma triglycerides ≥1.70 mmol\u002FL or current lipid-lowering treatment Plasma HDL-C: \\\u003C1.0 mmol\u002FL (male) or \\\u003C1.3 mmol\u002FL (female) or active lipid-modifying therapy -\n\nExclusion Criteria: Patients who are pregnant or breastfeeding. Excessive alcohol consumption: ethanol intake greater than 210g\u002Fweek for males and greater than 120g\u002Fweek for females (according to the \"Guidelines for the Prevention and Treatment of Metabolic Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)\") Individuals co-infected with HIV. Patients co-infected with HCV virus or other viral hepatitis and other chronic liver diseases.\n\nPatients with liver cirrhosis (compensated or decompensated), liver failure, hepatocellular carcinoma, or any type of malignant tumor.\n\nPatients with serious heart, brain, kidney, and hematopoietic system diseases or oncologic diseases.\n\nPatients with severe psychiatric abnormalities as well as uncontrolled hypertension, diabetes, thyroid dysfunction, etc.\n\nPeripheral blood leukocyte count \\\u003C3.5×10\\^9\u002FL and\u002For platelet count \\\u003C80×10\\^9\u002FL. Patients allergic to interferon, as well as those with contraindications to interferon indicated in the package insert.\n\nPatients deemed unsuitable for enrollment by the researcher.\n\n\\-",{"count":101,"type":21},830,[103],"PHASE4","Background Chronic hepatitis B (CHB) is a global health issue that affects a large number of patients. There is currently controversy regarding the treatment strategies for CHB patients with metabolic-associated steatoliver disease (MASLD). Therefore, this study aims to conduct a prospective cohort study to compare the therapeutic effects of pegylated interferon α-2b (Peg IFNα-2b) combined with nucleos(t)ide analogues (NAs) in CHB patients with and without MASLD, and to explore the metabolic improvement effects of Peg IFNα-2b treatment in CHB patients with MASLD.\n\nDesign This study is a single-center, non-randomized controlled clinical trial. The subjects are CHB patients planned to receive Peg IFNα-2b combined with NAs, who will be naturally divided into two groups based on the presence or absence of MASLD. The study period is from September 15, 2024, to December 31, 2029, with a planned enrollment of 830 patients.\n\nMethods Inclusion Criteria: Adults aged 18 to 65 years, with HBsAg positivity for more than 6 months, HBeAg negativity, HBsAg level ≤1500 IU\u002Fml, ALT \\\u003C10 ULN (400 IU\u002FL), no interferon treatment in the past year, and signed informed consent.\n\nGrouping Criteria: Patients will be divided into two groups based on the presence or absence of MASLD. MASLD is defined by hepatic steatosis confirmed by imaging or liver biopsy, and the presence of at least one of the following five metabolic factors: BMI ≥23 or waist circumference exceeding the standard, abnormal blood glucose, blood pressure ≥130\u002F85 mmHg, plasma triglycerides ≥1.70 mmol\u002FL, and abnormal plasma high-density lipoprotein cholesterol.\n\nExclusion Criteria: Pregnant or breastfeeding patients, heavy drinkers, patients with HIV infection, co-infected with other viral hepatitis, patients with liver cirrhosis or hepatocellular carcinoma, severe cardiocerebrovascular or renal diseases, psychiatric abnormalities, abnormal peripheral blood leukocytes or platelet count, interferon allergy, etc.\n\nWithdrawal Criteria: Patients who withdraw informed consent, request to exit, experience severe adverse events, have serious protocol violations, become pregnant, have poor compliance, are lost to follow-up, or whose continued participation in the study is deemed unsafe by the investigator.\n\nResearch Endpoints Primary Endpoint: HBsAg clearance rate at 48 weeks of treatment. Secondary Endpoints: Proportion and baseline reduction of HBsAg \\\u003C1500 IU\u002Fml at the end of treatment, reduction of HBV DNA levels from baseline and proportion below the detection limit, clearance and seroconversion rates of HBeAg in HBeAg-positive patients, and the incidence of cardiovascular disease in MASLD patients at the end of treatment.\n\nConclusion This study aims to provide evidence for the individualized treatment of CHB patients with MASLD, clarify the impact of MASLD on the treatment response of CHB patients, optimize treatment protocols, increase clinical cure rates, and explore new strategies for improving patients' metabolic functions. Through this study, we hope to provide more precise decision-making support for clinicians, thereby improving patients' quality of life and long-term prognosis.",[106,56],"Metabolic Dysfunction-Associated Steatotic Liver Disease","2025-07-08",{"date":109,"type":32},"2025-07-17",{"date":111,"type":21},"2025-08-15",{"date":113,"type":21},"2029-09-30",{"name":38,"class":39},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100586531","phase-2-chinese-phase-ii-trail-of-as1501-in-acute-on-chronic-liver-failure-aclf-patients-100586531","NCT06916585","Chinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients","A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Injectable AS1501 in the Treatment of Acute-on-chronic Liver Failure (ACLF)","Inclusion Criteria:\n\n* The age range for signing the informed consent form is between 18 and 75 years old\n* According to the \"Diagnosis and Treatment Guidelines for Liver Failure (2018 Edition)\" issued by the Liver Failure and Artificial Liver Group of the Infectious Diseases Branch of the Chinese Medical Association and the Severe Liver Disease and Artificial Liver Group of the Hepatology Branch of the Chinese Medical Association, it has been diagnosed with chronic acute liver failure, with specific indicators including:\n\n  1. Patients with chronic liver disease (chronic hepatitis B, autoimmune hepatitis, drug-induced hepatitis, etc.) and the acute attack factor is drugs;\n  2. Serum TBil ≥ 10 × ULN or average daily increase ≥ 17.1 μ mol\u002FL;\n  3. Meet any of the following three criteria: A has a tendency to bleed, PTA ≤ 40% (or INR ≥ 1.5); B combined with hepatic encephalopathy; C combined with hepatorenal syndrome or ascites.\n* Screening was conducted in the early stage of liver failure and did not meet the criteria for liver transplantation;\n* Early manifestations of liver failure:\n\nExtreme fatigue, accompanied by severe gastrointestinal symptoms such as anorexia, vomiting, and bloating; ALT and\u002For AST continue to significantly increase, and jaundice progressively deepens (TBil\\>171 μ mol\u002FL or daily increase\\>17.1 μ mol\u002FL); There is a tendency for bleeding, with 30%\\\u003CPTA ≤ 40% (or 1.5 ≤ INR\\\u003C1.9); No complications or other extrahepatic organ failure.\n\n* During the screening period, serum TRAIL levels increased and were ≥ 3 times higher than normal human TRAIL levels;\n* Can understand the informed consent form, voluntarily participate and sign the informed consent form;\n* Capable of completing experiments in accordance with the research protocol;\n* The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures within 6 months after the last administration of the investigational drug.\n\nExclusion Criteria:\n\n* Patients with a history of allergies or severe allergies to protein drugs (CTCAE v5.0 score\\>grade 3);\n* Patients who have completed liver transplantation or plan to undergo liver transplantation within one month.\n* ACLF patients in the middle and late stages; Severe grade III ascites or refractory ascites accompanied by stage III-IV hepatic encephalopathy.\n* Individuals who have received artificial liver treatment within one week prior to screening.\n* Individuals with malignant tumors or a history of malignant tumors in the past; Patients with lung cancer, liver cancer, pancreatic cancer, gastrointestinal tract and other tumors were diagnosed by imaging (ultrasound, CT or MRI) and tumor markers (AFP, CEA, CA125 or CA199, etc.) during the screening period or within one month before the screening period.\n* Individuals who have undergone gastroscopy or imaging (abdominal B-ultrasound, CT, or MRI) during the screening period or within one month prior to screening, and whose results indicate a risk of severe varicose veins with bleeding.\n* Subjects with acute kidney injury (AKI) defined by KDIGO criteria: (1) Scr elevation ≥ 26.5 μ mol\u002FL (0.3mg\u002FdL, 1mg\u002FdL=88.4 μ mol\u002FL) within 48 hours; (2) Scr increases by 1.5 times or more than the baseline value within 7 days; (3) Decreased urine output (\\\u003C0.5ml\u002Fkg\u002Fh) and lasting for more than 6 hours.\n* There are the following laboratory test values or abnormal test values: a. Blood routine: platelet count (PLT)\\\u003C75 × 109\u002FL, hemoglobin (HGB)\\\u003C80g\u002FL; b. PT-INR\\>1.9 or PTA\\\u003C30%; c. Left ventricular ejection fraction (LVEF)\\\u003C50%; Blood creatinine\\>1.5 × ULN.\n* Patients with severe respiratory dysfunction, difficulty breathing, or failure.\n* Severe infections that cannot be controlled by concomitant medications, including infections of major organs such as the abdominal cavity, lungs, urinary tract, and skin.\n* HIV positive individuals, or active tuberculosis or syphilis infected individuals.\n* Individuals with a history of unstable ischemic heart disease, congestive heart failure, myocardial infarction, stroke, severe arrhythmia, etc.\n* Subjects with uncontrolled severe hypertension or diabetes.\n* Pregnant or lactating women, or those who test positive for pregnancy.\n* Participants in clinical trials of other drugs or medical devices within 30 days prior to randomization or within five drug half lives.\n* Having undergone trauma or major surgery (e.g. requiring general anesthesia) within 28 days prior to the first administration of the investigational drug. Note: Participants who plan to undergo surgical procedures under local anesthesia are eligible to participate in the study.\n* Any serious underlying medical or mental condition (such as alcohol or drug abuse), dementia, or change in mental state; Or any issues that may impair the subject's ability to receive or tolerate planned treatment at the research center, understand informed consent, or issues that the researcher deems taboo to participate in the study or confound the evaluation or study results specified in the protocol.\n* Researchers believe that other conditions are not suitable for participating in this study.","75 Years",{"count":124,"type":21},96,[126],"PHASE2","\\*\\*Document Name: This Trial is a Phase II Clinical Study.docx\\*\\* \\*\\*Document Content:\\*\\*\n\n* This trial is a Phase II clinical study, conducted in two stages:\n* \\*\\*Phase IIa:\\*\\* A sentinel, single-arm design will be employed. A total of 12 early ACLF subjects are expected to be enrolled in the 0.5 mg\u002Fkg dose group. The first 2 subjects will serve as sentinels and be enrolled sequentially to receive a single intravenous dose. If no drug-related SAEs (Serious Adverse Events) occur in these 2 sentinel subjects within 2 weeks after the first dose, the remaining 10 subjects will be enrolled. Otherwise, the dose will be reduced for further exploration. After receiving a single intravenous dose, subjects will undergo a 20-day washout period. If no drug-related ≥Grade 3 AEs (Adverse Events) occur during this 20-day washout period, and safety\u002Ftolerability is jointly confirmed by the investigator and sponsor, the subject will enter the multiple-dose phase (once weekly \\[Day 21 as the first dose of multiple administration\\], for 4 consecutive weeks). If any drug-related ≥Grade 3 AE occurs, the dose will be reduced for further exploration, with the specific dose determined by the sponsor and investigator. If a subject drops out during the washout period after a single dose, additional subjects may be enrolled to ensure at least 12 subjects enter the multiple-dose phase.\n* After all 12 early ACLF subjects in the 0.5 mg\u002Fkg dose group complete continuous dosing, the DMC (Data Monitoring Committee) will assess the safety of this dose group. If any of the following occur in the 0.5 mg\u002Fkg group, the DMC will discuss whether to proceed with dose escalation:\n\n\\> 1) ≥1\u002F3 of subjects experience drug-related Grade 3 SAEs; \\> 2) Any drug-related Grade 4 or higher SAEs.\n\n* If the DMC determines that dose escalation criteria are met, an additional 12 early ACLF subjects will be enrolled to receive the 1 mg\u002Fkg dose group. The same enrollment rules as the 0.5 mg\u002Fkg group apply: the first 2 subjects are sentinels receiving a single intravenous dose. If no drug-related SAEs occur in these sentinels within 2 weeks post-dose, the remaining 10 subjects will be enrolled. Post-single-dose administration, subjects will undergo a 20-day washout period. If no drug-related ≥Grade 3 AEs occur during this period, and safety\u002Ftolerability is confirmed, subjects will enter the multiple-dose phase (once weekly \\[Day 21 as the first dose\\], for 4 consecutive weeks). Dropouts during the washout period may be replaced to ensure at least 12 subjects enter the multiple-dose phase.\n* After completing the 0.5 mg\u002Fkg and 1 mg\u002Fkg dose exploration studies, the investigator and sponsor may determine the recommended dose for Phase IIb based on cumulative safety, efficacy, and potential PK\u002FPD results. Additional dose groups or alternative administration frequencies may also be explored.\n* \\*\\*Phase IIb:\\*\\* A randomized (1:1), double-blind, placebo-controlled design will be used. A total of 72 ACLF subjects are expected to receive either AS1501 at the appropriate dose\u002Ffrequency or placebo to further evaluate the efficacy and safety of AS1501 injection. The specific design will be finalized based on Phase IIa results and agreed upon by the investigator and sponsor.",[129],"Acute-On-Chronic Liver Failure","2025-04-07",{"date":132,"type":32},"2025-04-09",{"date":134,"type":21},"2025-04-15",{"date":136,"type":21},"2027-12-31",{"name":38,"class":39},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100557740","application-of-nanopore-adaptive-sequencing-100557740","NCT06542042","Application of Nanopore Adaptive Sequencing","Application of Oxford Nanopore Adaptive Sequencing Method in Infection Post Liver Transplantation","Inclusion Criteria:\n\n* Accept liver transplantation\n* Signing informed consent voluntarily\n* Possessing ability to comprehend material information\n* Participating this study voluntarily\n\nExclusion Criteria:\n\n* Participated another study\n* Graft loss\n* Have undergone a multi-organ transplantion or have had a previous organ transplantation\n* Patient died",{"count":146,"type":21},100,"Infection post liver transplantation is an important factor in the death in patients. The traditional method of diagnosing infection post liver transplantation is laboratory tests. But the sensitivity and specificity of blood tests is poor. Next-generation sequencing (NGS) has greater detection rate for mycobacterium tuberculosis, anaerobes and fungi and greater sensitivity compare with blood tests. However use of NGS is limited because of the short read-length. Oxford nanopore adaptive sequencing (NAS) method is the Third Revolution in Sequencing Technology. For each 1 Gbp of data, NAS sequencing detected 45 times more microbiome sequences than Nanopore standard sequencing and 2.5 times more than Illumina sequencing. The purpose of this study is to compare NAS with NGS and laboratory tests for the diagnostic rate of infection post liver transplantation.",[149],"Liver Transplant Infection",[151],"Oxford nanopore adaptive sequencing method","2024-08-06",{"date":154,"type":32},"2024-08-07",{"date":156,"type":21},"2024-10-01",{"date":158,"type":21},"2026-10-30",{"name":38,"class":39},1,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":160},"100554802","comparison-of-application-effects-between-long--and-standard-short--peripheral-venous-catheters-100554802","NCT06503822","Comparison of Application Effects Between Long- and Standard Short- Peripheral Venous Catheters","Comparison of Application Effects Between Long Peripheral Venous Catheters and Standard Short Peripheral Venous Catheters: A Multicenter Prospective Randomized Controlled Trial Study","Inclusion Criteria:\n\n1. A male or female aged 18 years or older who is able and willing to give written informed consent;\n2. Identification of the patient's medical diagnosis based on the competent physician and the study nurse at any time during the hospital stay, and judgment that the duration of peripheral intravenous infusion therapy needs to exceed 4 days;\n3. Subjects with good compliance and can cooperate with catheter maintenance and observation.\n\nExclusion Criteria:\n\n1. Patients who are delirious and unable to cooperate;\n2. Patients requiring central venous access;\n3. Patients suffering from connective tissue diseases or blood diseases;\n4. Patients allergic to catheters or dressings;\n5. any subject in a condition deemed by the investigator to interfere with the evaluation of results or pose a health risk to the subject.",{"count":169,"type":21},250,[171],"NA","Short PIVC (intravenous indentation needle) accounts for more than 50% of clinical infusion tools, but long PIVC is rarely used and studied in China. This study aims to explore the application characteristics and application effects of long PIVC in China. It provides reference for the correct selection of infusion tools, and promotes the clinical application and promotion of new intravenous therapy tools.\n\nThe study nurse will work with the responsible physician to assess the eligibility for enrollment and sign the informed consent. Were randomly assigned to the control group (to receive a new 24G\u002F22G (0.7mm\\*19mm\u002F0.9mm\\*25mm) short PIVC (closed needle protected venous catheter system) puncture) or the intervention group (to insert a new 3F (8cm) or 4F(10cm) long PIVC) for daily routine maintenance until catheter removal, General demographic data, laboratory-related data, catheter-related data, catheter-related complications (unplanned extubation, phlebitis, catheter blockage, catheter-related thrombosis, catheter-related bloodstream infection, exudation, etc.) and patient satisfaction were collected.",[174],"Hospitalized Patients","2024-07-14",{"date":177,"type":32},"2024-07-16",{"date":179,"type":32},"2023-12-05",{"date":181,"type":21},"2024-12-31",{"name":38,"class":39},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":190,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":160},"100532385","anti-infection-therapy-based-on-mngs-etiological-diagnosis-and-infection-after-liver-transplantation-100532385","NCT06212115","Anti-infection Therapy Based on mNGS Etiological Diagnosis and Infection After Liver Transplantation","The Effect of Donor-oriented Anti-infection Therapy Based on mNGS Etiological Diagnosis on the Incidence of Perioperative Infection and Prognosis of Corresponding Recipients After Liver Transplantation","Inclusion Criteria:\n\n* Recipient age \\>18 years;\n* Clinical diagnosis of infection in the donor with administered anti-infective treatment;\n* Complete clinical data for both the donor and recipient.\n\nExclusion Criteria:\n\n* Recipient age \\\u003C18 years;\n* Presence of surgery-related factors leading to death or infection, such as intraoperative cardiac arrest resulting in postoperative death, intraoperative bleeding exceeding 2000ml, postoperative complications like intestinal or bile leakage, graft dysfunction, or small liver syndrome;\n* Incomplete clinical data for the donor or recipient",{"count":81,"type":21},"Liver transplantation is the most efficacious treatment for end-stage liver disease; however, postoperative infection remains a major complication and leading cause of recipient mortality. Specifically, infections originating from donors, particularly those caused by multidrug-resistant bacteria, can significantly impact the prognosis of liver transplant recipients. Theoretically, implementing targeted antimicrobial therapy for donors prior to organ donation could reduce the likelihood of pathogen transmission with the transplanted organ, thereby potentially decreasing the incidence of post-transplant infections from donor sources and improving recipient outcomes. Nevertheless, there is currently a dearth of high-quality prospective studies in this domain. Our previous investigation (Front Microbiol. 2022 Jul 1;13:919363) demonstrated that second-generation metagenomic sequencing (mNGS) technology holds substantial value in expeditious pathogen screening following liver transplantation. Prompt implementation of targeted treatment based on microbiological findings has shown potential to enhance outcomes for select recipients. Therefore, this study aims to provide tailored treatment for donors based on microbiological examination results (including mNGS detection and culture results), analyze corresponding data regarding recipient infection occurrence and prognosis, and explore the impact of mNGS-guided donor antimicrobial therapy on perioperative infection rates among liver transplant recipients.",[193],"Infection","2024-01-17",{"date":196,"type":32},"2024-01-19",{"date":198,"type":21},"2024-02-01",{"date":200,"type":21},"2027-12-30",{"name":38,"class":39},""]