[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574789":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":63,"collaborators":66,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group","EXPERIMENTAL","The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume. Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).",[13],"Device: Protein A immunoadsorption",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","ACTIVE_COMPARATOR","The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).",[19],"Drug: intravenous methylprednisolone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Protein A immunoadsorption","The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","intravenous methylprednisolone","The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Wei Qiu, Ph.D","CONTACT","+8615899968330","qiuwei120@vip.163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The Third Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","518000","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54,56,60],{"name":55,"role":35,"phone":36,"phoneExt":26,"email":37},"Wei Qiu, MD; phD",{"name":57,"role":35,"phone":58,"phoneExt":26,"email":59},"Jiahao Lin, phD","13411161510","linjh95@mail2.sysu.edu.cn",{"name":61,"role":62,"phone":26,"phoneExt":26,"email":26},"Wei Qiu, MD;phD","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Wei Qiu","Chief Physician",[67,69,71,73],{"name":68,"class":6},"Second Affiliated Hospital of Guangzhou Medical University",{"name":70,"class":6},"Guangdong 999 Brain Hospital",{"name":72,"class":6},"Second Xiangya Hospital of Central South University",{"name":74,"class":6},"Beijing Friendship Hospital","100574789","protein-a-immunoadsorption-for-the-treatment-of-acute-episodes-of-neuromyelitis-optica-spectrum-disorder-100574789",false,"NCT06763848","Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder","Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial","PANDA","Inclusion Criteria:\n\n* The inclusion criteria for the study are as follows:\n\n  1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)\n  2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.\n  3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.\n  4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.\n3. Participants with contraindications to intravenous methylprednisolone treatment.\n4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.\n5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.\n6. Severe Bleeding or Bleeding Disorders\n7. Severe Heart Failure\n8. Severe Infections","ALL","18 Years","65 Years",{"count":87,"type":88},144,"ESTIMATED","INTERVENTIONAL",[91],"NA","To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.",[94],"Neuromyelitis Optica Spectrum Disorders",[96,97,98,99],"neuromyelitis optica spectrum disorders","immunoadsorption","acute episodes","treatment","2025-04-27",{"date":102,"type":103},"2025-04-30","ACTUAL",{"date":105,"type":103},"2025-04-25",{"date":107,"type":88},"2026-12-31",{"name":5,"class":6},1]