[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626460":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":39,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":10,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Healthgen Biotechnology Corp.","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Recombinant Human Serum Albumin From Oryza Sativa",null,[12],"Drug: Recombinant Human Serum Albumin From Oryza Sativa",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"DRUG","The treatment of the study drug will be solely determined by the attending physician based on the patient's condition and clinical guidelines.",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Yuemin Lan, MD","CONTACT","+86-185 3311 2266","nanyuemin@163.com",[25],{"facility":26,"status":10,"city":27,"state":28,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Hebei medical university third hosipital","Shijiazhuang","Hebei","China","CN",{"type":32,"coordinates":33},"Point",[34,35],114.47861,38.04139,{"lat":35,"lon":34},[38],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},{"type":40,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":51,"type":52},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.",[56,57],"Hypoalbuminemia","Hypovolemia","NOT_YET_RECRUITING","2026-02-26",{"date":61,"type":62},"2026-03-02","ACTUAL",{"date":64,"type":52},"2026-02-24",{"date":66,"type":52},"2026-12-31",{"name":5,"class":6},1]