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在慢性炎症性脱髓鞘性多发性神经病(CIDP)患者中研究efgartigimod PH20 SC给药的长期安全性、耐受性和有效性的开放性扩展研究

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研究单位: [1]复旦大学附属华山医院 [2]首都医科大学宣武医院 [3]华中科技大学同济医学院附属同济医院 [4]吉林大学第一医院 [5]山东大学齐鲁医院 [6]浙江大学医学院附属第一医院(浙江省第一医院) [7]南昌大学附属第一医院 [8]四川省人民医院 [9]南方医科大学南方医院 [10]山西医科大学第一医院 [11]中南大学湘雅医院 [12]西安高新医院有限公司 [13]福建医科大学附属协和医院 [14]香港大学深圳医院 [15]南京市第一医院 [16]南昌大学附属第二医院 [17]贵州医科大学附属医院 [18]广东省中医院 [19]赤峰市医院 [20]复旦大学附属中山医院 [21]武汉大学人民医院(湖北省人民医院) [22]江西省人民医院 [23]同济大学附属杨浦医院 [24]浙江省人民医院 [25]西安唐都医院(中国人民解放军空军军医大学第二附属医院) [26]延安大学咸阳医院 [27]Neiro-Clinica,LLC [28]Medical Center Convex EOOD [29]Austin Neuromuscular Center [30]Jüdisches Krankenhaus [31]Hiroshima University Hospital [32]Pineo Medical Ecosystem [33]Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz [34]Republican Clinical Hospital #4 [35]Michigan State University [36]Research Medical Complex Vashe Zdorovie [37]IMMUNOe Research Centers [38]Saitama Medical Center [39]Chiba University Hospital [40]CHU de Nice [41]CHU Bicêtre [42]Columbia University Medical Center [43]Nagoya University Hospital [44]Municipal enterprise Volyn Regional Clinical Hospital of Volyn Regional Council [45]Neuromuscular Research Center [46]Kindai University Hospital [47]Medical Clinical Research Center of Medical Center LLC Health Clinic [48]University of Kansas Medical Center [49]Tel Aviv Sourasky Medical Center PPDS [50]Yale University School of Medicine [51]Ospedale Policlinico San Martino [52]Ohio State University [53]California Pacific Medical Center [54]University Clinical Center of Serbia - PPDS [55]Academisch Medisch Centrum Amsterdam [56]Republican Clinical Neurological Center [57]Military Medical Academy HBAT [58]University of South Florida [59]Universitatsklinikum Schleswig-Holstein [60]Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico [61]Sarajishvili Institute of Neurology [62]Universitatsklinikum Leipzig [63]Teikyo University Hospital [64]Keio University Hospital [65]Kyushu University Hospital [66]Edith Wolfson Medical Center [67]Azienda Ospedaliera Universitaria Careggi [68]Erasmus MC [69]University of California Irvine [70]University of Texas - San Antonio - Health Science Center - PPDS [71]Hospital General Universitario de Alicante [72]Odense Universitetshospital [73]Neurology Associates PA [74]Hospital Clinico San Carlos [75]Medizinische Hochschule Hannover [76]North County Neurology Associates [77]Azienda Ospedaliero Universitaria Pisana [78]Multiprofile Hospital for Active Treatment of Neurology and Psychiatry [79]Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC [80]Krakowski Szpital Specjalistyczny im. Jana Pawla II [81]Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta [82]Az Ospedaliera Universitaria Policlinico G Martino [83]Azienda Ospedaliera Universitaria Federico II [84]Azienda Ospedaliera Sant'andrea [85]UZ Leuven [86]Medical University of Vienna [87]University of Pennsylvania [88]ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN [89]Hospital For Special Surgery [90]UZ Brussel [91]Azienda Ospedaliera Universitaria Senese [92]Pest Megyei Flór Ferenc Kórház [93]University Clinical Center Kragujevac [94]Charité - Universit?tsmedizin Berlin [95]Kepler Universit?tsklinikum Linz [96]University of Virginia [97]APHP Raymond Poincare [98]Rostov State Medical University [99]Neurological Services of Orlando [100]Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates PC [101]Military Medical Academy [102]University of Alabama at Birmingham [103]University of Minnesota [104]Sheba Medical Center - PPDS [105]Wayne State University [106]Hokkaido University Hospital [107]University of Florida Jacksonville [108]Affidea Romania SRL [109]Osaka University Hospital [110]University of Cincinnati Medical Center [111]Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council [112]Medical Hospital of Tokyo Medical and Dental University [113]University of North Carolina at Chapel Hill [114]HonorHealth Neurology [115]SFM Clinical Research,LLC [116]Medical Center of LLC Medical Center Dopomoga-Plus [117]Rutgers University- Robert Wood Johnson Medical School [118]Centre Hospitalier et Universitaire de Limoges [119]Uniwersyteckie Centrum Kliniczne WUM,Centralny Szpital Kliniczny [120]Prime Site Kft. [121]Specjalistyczne Gabinety Sp. z o.o. [122]Tokyo Metropolitan Nuerological Hospital [123]Teo Health S.A. [124]S.C. Neurocity S.R.L. [125]St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH [126]Privatni ordinace neurologie [127]Aarhus Universitetshospital [128]Niigata University Medical and Dental Hospital [129]VCU Neuroscience Orthopaedic and Wellness Center (NOW) [130]Centrum Neurologii Krzysztof Selmaj [131]Duke University School of Medicine [132]National Center of Neurology and Psychiatry [133]Municipal Non-profit Institution City Hospital #2 Zaporizhzhia city council [134]Treatment and diagnostic center Neuro Global [135]Kitasato University Hospital [136]Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital [137]Aversi Clinic LTD [138]Centre Hospitalier Universitaire de Bordeaux,Hopital Pellegrin [139]S. Khechinashvili University Clinic,Ltd. [140]Riga East Clinical University Hospital [141]University of Iowa [142]Research Center of Neurology [143]Dokkyo Medical University Hospital [144]Tokushima University Hospital [145]Novo-Med Zielinski i wsp. Sp.J. [146]NHO Okinawa Hospital [147]Pius Brinzeu Emergency Clinical County Hospital [148]Christian-Doppler-Klinik Salzburg [149]University of Pittsburgh Medical Center [150]University Multiprofile Hospital for Active Treatment Aleksandrovska EAD [151]Hospital Universitario Vall d'Hebron - PPDS [152]LLC “Medical Center ”Reavita Med SPb [153]University Hospital Antwerp [154]C.H. Regional Reina Sofia - PPDS [155]济宁医学院附属医院

研究目的:
评估efgartigimod PH20 SC的长期安全性和耐受性。次要目的为确定长期有效性,评价efgartigimod和rHuPH20的免疫原性(抗药抗体[ADA])、PK、PD、其他患者报告结局(PRO)(包括患者报告的生活质量和治疗满意度)、探索治疗中的自我给药。

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