[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Healthgen Biotechnology Corp.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100626460","evaluate-recombinant-human-serum-albumin-from-oryza-sativa-in-patients-with-hypoalbuminemia-andor-hypovolemia-requiring-urgent-treatment-100626460",false,"NCT07435922","Evaluate Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and\u002For Hypovolemia Requiring Urgent Treatment","Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and\u002For Hypovolemia Requiring Urgent Treatment: A ReaL World Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Hypoalbuminemia and\u002For hypovolemia requiring urgent treatment.\n* Agree to participate in this study and sign a written informed consent form by the subject themselves or their legal representative (guardian).\n* In real-world clinical practice, the attending physician has decided and planned to administer at least one dose of human albumin injection.\n\nExclusion Criteria:\n\n* Known allergy to the active ingredients or any excipients of this product.\n* Any medical condition that, in the investigator's judgment, may significantly increase the subject's risk or interfere with their participation in and completion of this study.\n* Participation in any other clinical trial of a drug at the time of enrollment in this study.","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","OBSERVATIONAL","This study is a post-marketing, multicenter, prospective, open-label observational study. It plans to enroll approximately 2,000 patients with hypoalbuminemia and\u002For hypovolemia requiring urgent treatment who are scheduled to receive at least one dose of Recombinant Human Albumin from Oryza Sativa. The study does not interfere with clinical diagnosis and treatment; the use of the study drug is solely determined by the attending physician based on the patient's condition and clinical guidelines.\n\nStudy data will be collected during the patient's participation in the study, including baseline characteristics, medical history, concomitant medications, records of study drug administration and reasons for use, serum albumin levels (baseline and end of treatment), adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events of special interest (AESIs). The follow-up period will primarily be conducted via telephone.\n\nThe primary endpoint of the study is the incidence of all adverse drug reactions (ADRs). Secondary endpoints include the incidence of all adverse events (AEs), the incidence of AEs by severity, the incidence of serious adverse events (SAEs), the incidence of adverse events of special interest (AESIs), and the incidence of AEs leading to dose interruption, dose reduction, discontinuation, or death related to Recombinant Human Albumin Injection from Oryza Sativa. Efficacy evaluations include changes in serum albumin concentration before and after treatment and assessment of volume restoration.",[24,25],"Hypoalbuminemia","Hypovolemia","NOT_YET_RECRUITING","2026-02-26",{"date":29,"type":30},"2026-03-02","ACTUAL",{"date":32,"type":20},"2026-02-24",{"date":34,"type":20},"2026-12-31",{"name":36,"class":37},"Healthgen Biotechnology Corp.","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100556451","phase-1-a-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-osrhct-in-patients-with-pleurisy-100556451","NCT06525272","A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With Pleurisy","A Phase 1 Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT Administered Intrathoracically in Single and Multiple Doses in Patients With Pleurisy","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent;\n2. Aged 18-65 years (inclusive), male or female;\n3. Clinical diagnosis of pleurisy (parapneumonic pleural effusion, empyema, tuberculous pleurisy, etc.);\n4. Patients with pleural effusion confirmed by chest ultrasound or CT examination and requiring chest tube drainage as assessed by the study physician, and the ultrasound report or CT image within one month shows that there are fibrous bands or encapsulated or septated effusions in the thoracic cavity;\n5. Patients who cannot be fully drained after open drainage for ≥ 3 hours after chest tube drainage and meet the following conditions: The maximum depth of pleural effusion detected by ultrasound is ≥ 2 cm;\n6. Women of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pills or condoms) during the study and within 3 months after the end of the study; men must agree to use effective contraception during the study and within 3 months after the end of study period.\n\nExclusion Criteria:\n\n1. Known allergy to the investigational drug or its excipients;\n2. Known or clinically highly suspected malignant pleural effusion;\n3. Received intrathoracic injection of fibrinolytic drugs (such as urokinase, streptokinase, and alteplase) within 1 month prior to enrollment;\n4. History of lung resection surgery on the same side as the chest tube drainage;\n5. Evidence of abdominal lesions (e.g., pancreatic cyst or renal cyst) communicating with the pleura;\n6. Currently using systemic corticosteroids and unable to discontinue;\n7. HIV antibody positive;\n8. History of organ transplantation;\n9. Severe cardiovascular, cerebrovascular, hematologic diseases, or malignancies;\n10. Abnormal laboratory values: hemoglobin \\\u003C80g\u002FL, total bilirubin \\>2×ULN (upper limit of normal), ALT \\>2.5×ULN, AST \\>2.5×ULN, creatinine \\>2×ULN; coagulation function APTT \\>1.5×ULN, or INR \\>1.5;\n11. Pregnant or breastfeeding women;\n12. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months (excluding diagnostic skin test);\n13. Any other conditions deemed unsuitable for the study by the investigator.","65 Years",{"count":48,"type":20},72,"INTERVENTIONAL",[51],"PHASE1","Primary Objectives:\n\nTo evaluate the safety and tolerability of single and multiple ascending doses of OsrhCT administered intrathoracically in patients with pleurisy, and to explore the DLT, MTD, and recommended effective dose of OsrhCT.\n\nSecondary Objectives:\n\nTo evaluate the preliminary efficacy of single and multiple intrathoracic doses of OsrhCT.\n\nPopulation:\n\nPatients diagnosed with pleurisy requiring chest tube drainage.\n\nInvestigational Products:\n\nInvestigational Drug: Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U\u002Fvial, freeze-dried powder, stored at 2-8°C.\n\nPlacebo:\n\nPlacebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.\n\nStudy Design:\n\nThe study comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), both employing a multicenter, randomized, double-blind, and placebo-controlled design.\n\nSample Size:\n\nA total of 72 subjects (both male and female) are expected to be enrolled in this trial, including 48 subjects for single-dose administration and 24 subjects for multiple-dose administration.",[54],"Pleurisy",[56,57],"OsrhCT","Recombinant Human Chymotrypsin","2024-07-24",{"date":60,"type":30},"2024-07-29",{"date":62,"type":20},"2024-07",{"date":64,"type":20},"2025-12",{"name":36,"class":37},4,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":49,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":38},"100426628","phase-2-a-phase-ii-study-of-osrhsa-in-patients-with-decompensated-cirrhotic-ascites-100426628","NCT04835480","A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites","A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites","Inclusion Criteria:\n\n1. Able to understand and willing to sign the ICF;\n2. Decompensated cirrhosis with ascites by clinical, laboratory, or imaging evidence. Male or female eligible; Age ≥18 years and ≤80 years;\n3. Serum albumin ≤30 g\u002FL;\n4. Has adequate venous access;\n5. Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and has a follicle stimulating hormone \\> 40mIU\u002FmL, or surgically sterile \\[defined as having a bilateral oophorectomy, hysterectomy or tubal ligation\\]) or a woman of childbearing potential who agrees to one of the following to prevent pregnancy and has a negative serum pregnancy test at screening:\n\n   * Practicing abstinence;\n   * If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 90 days after the administration of the investigational product:\n\n     * simultaneous use of the intrauterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;\n     * simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;\n     * simultaneous use of a diaphragm with intravaginally applied spermicide and male condoms for the male partner, starting at least 21 days prior to study drug administration.\n   * Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of randomized study drug until 90 days after their dose and must not donate sperm during their study participation period:\n\n     * simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intrauterine contraceptive device (placed since at least 4 weeks);\n     * simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide.\n\nExclusion Criteria:\n\n1. Previous known allergic\u002Fadverse reaction to cereal or any food containing cereal, including rice; A history of a severe allergic reaction to any HpHSA component or any food;\n2. Positive IgE and IgG against rice at the screening, i.e. anti-rice Ig E ≥ 0.35 kU\u002FL and anti-rice Ig G ≥ 25.0 mgA\u002FL;\n3. Subjects who have medical conditions except for hepatic cirrhosis, currently requiring the use of albumin such as paracentesis-induced circulatory dysfunction, large- volume paracentesis (\\>5 L each time);\n4. Nephrotic syndrome, hepatorenal syndrome or Creatinine \\>2 × upper limit of normal (ULN), significant cardiopulmonary or structural heart disease, hemodialysis, active upper gastrointestinal bleeding, subjects with hepatic encephalopathy Grade III or IV (see Appendix 5 for hepatic encephalopathy stages);\n5. Malignant ascites or ascites caused by cancer embolus;\n6. Subjects with Grade C or D liver cancer according to the Barcelona-Clinic Liver Cancer staging (See Appendix 6);\n7. Pregnancy;\n8. HIV positive;\n9. Active obstructive disease in the biliary tract defined by ultrasound or other imaging modalities;\n10. With the following abnormal laboratory test values:\n\n    Absolute neutrophil count (NE#) \\\u003C1.0 × 109\u002FL, platelets \\\u003C30 × 109\u002FL, white blood cells\\\u003C2.0 × 109\u002FL, hemoglobin \\\u003C75 g\u002FL; ALT and (or) AST \\>5 × ULN, total bilirubin \\> 5.0 ×ULN; PT INR \\> 2.0; Urine protein \\> 2+;\n11. Subjects with Stage C or D heart failure according to ACCF\u002FAHA Stage (See Appendix 7);\n12. Previous transplant;\n13. The mental state that prevents the subject from understanding the nature, extent, and consequences of the study;\n14. Any clinical condition that the Investigator considers would make the subject unsuitable for the trial.","80 Years",{"count":76,"type":20},220,[78],"PHASE2","The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g\u002FL or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.",[81],"Cirrhotic Ascites","RECRUITING","2021-11-11",{"date":85,"type":30},"2021-11-19",{"date":87,"type":30},"2021-03-22",{"date":89,"type":20},"2022-06-30",{"name":36,"class":37},""]