[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655087":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":25,"studyPopulation":25,"armGroups":80,"interventions":93,"overallOfficials":25,"centralContacts":102,"locations":25,"responsibleParty":108,"collaborators":25,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":25,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":134,"whyStopped":25,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":25},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":67},[9,13],{"measure":10,"description":11,"timeFrame":12},"Guillain-Barre Syndrome Disability Scale (GBS-DS)","Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.","week 4",{"measure":14,"description":15,"timeFrame":16},"Number and seriousness of adverse events","safety monitoring","Through study completion, an average of 2 years",[18,20,23,27,30,34,37,40,43,46,48,50,52,54,57,61,64],{"measure":10,"description":11,"timeFrame":19},"week 1，2，3，8，12，24",{"measure":21,"description":11,"timeFrame":22},"Change from baseline in Guillain-Barre Syndrome Disability Scale (GBS-DS)","week 1,2,3,4,8,12,24",{"measure":24,"description":25,"timeFrame":26},"Number of days to GBS-DS ≤2 within 24 weeks",null,"24 weeks",{"measure":28,"description":25,"timeFrame":29},"Proportion of patients with GBS-DS ≤2","week 1, 2, 3, 4, 8, 12, and 24",{"measure":31,"description":32,"timeFrame":33},"Neuropathy Impairment Scale (NIS)","Peripheral neuropathy assessment. Scores range from 0 to 244, with higher scores indicating a worse outcome","week 1,4,8,12,24",{"measure":35,"description":36,"timeFrame":33},"Inflammatory Rasch-Built Overall Disability Scale (I-RODS)","Functional outcome assessment. Scores range from 0 to 48, with higher scores indicating a better outcome",{"measure":38,"description":39,"timeFrame":33},"Inflammatory Neuropathy Cause and Treatment (INCAT) Scale","Functional outcome assessment. Scores range from 0 to 5 for upper limbs or lower limbs, with higher scores indicating a worse outcome",{"measure":41,"description":42,"timeFrame":33},"Medical Research Council Sum Score（MRC-SS）","Quantifies strength.Scores range from 0 to 60, with a higher score indicating more strength.",{"measure":44,"description":45,"timeFrame":33},"Modified Rankin Scale (mRS)","Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0 to 6,with higer scores indicating a worse outcome",{"measure":47,"description":25,"timeFrame":26},"Incidence of assisted mechanical ventilation",{"measure":49,"description":25,"timeFrame":26},"Duration of mechanical ventilation (hours)",{"measure":51,"description":25,"timeFrame":26},"Number of days in an intensive care unit",{"measure":53,"description":25,"timeFrame":26},"Number of days to hospital discharge",{"measure":55,"description":56,"timeFrame":26},"Hospitalization cost (inpatient cost)","CNY (Chinese Yuan) Total direct medical costs incurred during the index hospitalization for the study disease, including bed fees, medications, laboratory and imaging tests, nursing, and medical materials, as recorded in the hospital billing system or inpatient settlement records.Indirect costs (e.g., lost productivity, transportation, caregiver costs) are not included unless otherwise specified.",{"measure":58,"description":59,"timeFrame":60},"Forced Vital Capacity (FVC)","Pulmonary function test that measures the maximum amount of air you can forcibly exhale from your lungs after fully inhaling. Units are Liters and percentages, when comparing to a predicted value.","week 4,12,24",{"measure":62,"description":63,"timeFrame":60},"Maximal Inspiratory Pressure (MIP)","Pulmonary function test that evaluates the strength of inspiratory muscles, primarily the diaphragm. Units are cm H2O (centimeters of water)",{"measure":65,"description":66,"timeFrame":60},"Maximal Expiratory Pressure (MEP)","Pulmonary function test that evaluates the strength of expiratory muscles. Units are cm H2O (centimeters of water).",[68],{"measure":69,"description":70,"timeFrame":71},"Study effect of Efgartigimod on IgG levels","Blood sample to analyze change in IgG levels","week 1, 2, 3 ,4 ,8 ,12 ,24",{"allocation":73,"interventionModel":74,"interventionModelDescription":25,"primaryPurpose":75,"observationalModel":25,"timePerspective":25,"maskingInfo":76},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":77,"maskingDescription":25,"whoMasked":78},"SINGLE",[79],"OUTCOMES_ASSESSOR",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Intravenous Immunoglobulin (IVIg)","ACTIVE_COMPARATOR","0.4g\u002Fkg of IVIg daily for 5 days\n\nInterventions:\n\nDrug: Intravenous Immunoglobulin (IVIg)",[86],"Drug: Intravenous immunoglobulin (IVIG)",{"label":88,"type":89,"description":90,"interventionNames":91},"Efgartigimod Alfa-Fcab","EXPERIMENTAL","20mg\u002Fkg of Intravenous efgartigimod on days 1 and 5\n\nInterventions:\n\nDrug: Efgartigimod Alfa-Fcab",[92],"Drug: Efgartigimod Alfa-Fcab",[94,99],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":25},"DRUG","Intravenous immunoglobulin (IVIG)","IVIg is the standard-of-care treatment for GBS. The same brand of intravenous immunoglobulin (IVIG) was administered across different study sites",[82],{"type":95,"name":88,"description":100,"armGroupLabels":101,"otherNames":25},"Efgartigimod is an anti-neonatal Fc receptor (FcRn) immunoglobulin G1 Fc fragment. The FcRn plans a critical role in extending the half-life of IgGs by rescuing them from lysosomal degradation. Antibodies that bind and subsequently block the FcRn with high affinity result in IgGs being degraded more rapidly instead of salvaged. This approach has been shown to be beneficial in the antibody-mediated disorder myasthenia gravis.",[88],[103],{"name":104,"role":105,"phone":106,"phoneExt":25,"email":107},"Zaiqiang Zhang Zhang, MD","CONTACT","86-10-59975570","ttyy0142011@126.com",{"type":109,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Zaiqiang Zhang","Chief Physician,Professor","100655087","phase-2-efficacy-and-safety-of-efgartigimod-in-the-treatment-of-guillain-barr-syndromegreat-100655087",false,"NCT07806916","Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome(GREAT)","Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial","GREAT","Inclusion Criteria:\n\n1. Aged 18-70 years\n2. Diagnosis of sensorimotor or pure motor Guillain-Barré syndrome (GBS) based on the 2023 EAN\u002FPNS guidelines (corresponding to classical GBS in the Chinese Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2024).\n3. Onset of GBS within 14 days\n4. GBS Disability Scale (GBS-DS) score of 3 to 5\n\nExclusion Criteria:\n\n1. Patients with other diagnoses cannot be excluded\n2. Patients with recurrent GBS\n3. Patients with more than 14 days after onset of symptoms\n4. GBS DS of 2 or less\n5. Patients unable to cooperate with scale assessments due to psychiatric disorders or impaired consciousness\n6. Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection; Hepatitis C virus (HCV) based on HCV antibody assay; Positive HIV serology at screening\n7. Patients with any known severe bacterial, viral or fungal infection or any major episode of infection that required hospitalization or injectable antimicrobial therapy in the last 8 weeks prior to Screening\n8. Total IgG level ≤ 6 g\u002FL at screening\n9. Concomitant diseases that can cause peripheral neuropathy, such as metabolic neuropathies (e.g., diabetes, alcoholism), connective tissue disease-associated neuropathies (e.g., rheumatoid arthritis, Sjögren's syndrome, systemic lupus erythematosus), or trauma, which may confound the trial results\n10. Subjects with serious underlying diseases, such as cardiac dysfunction, coagulopathy dysfunction\n11. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing\n12. Patients who have a history of malignancy, including malignant thymoma, or myeloproliferative or lymphoproliferative disorders, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 3 years before Screening. Patients with completely excised non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ would be permitted at any time\n13. Use of investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to Screening\n14. Use of immunosuppressants, monoclonal antibodies, or other immunomodulatory drugs within 6 months prior to enrollment; use of corticosteroids at a dose exceeding 20 mg within 3 months prior to enrollment; or use of IVIG or plasma exchange (PE) within 1 month prior to enrollmen","ALL","18 Years","70 Years",{"count":124,"type":125},110,"ESTIMATED","INTERVENTIONAL",[128],"PHASE2","The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS). The main questions it aims to answer are:\n\nIs Efgartigimod a safe treatment option for GBS patients? Does treatment with Efgartigimod improve patient outcomes?\n\nParticipants will:\n\nTake drug Efgartigimod or Intravenous Immunoglobulin during hospitalization Undergo six blood draws in six follow-up study visits to evaluate the concentration of IgG Keep a diary of their symptoms and drugs using at the same time",[131],"Guillain-Barré Syndrome",[133,131],"Efgartigimod","NOT_YET_RECRUITING","2026-09-15",{"date":137,"type":138},"2026-09-18","ACTUAL",{"date":140,"type":125},"2026-09",{"date":142,"type":125},"2027-12",{"name":5,"class":6}]