[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587773":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":71,"collaborators":25,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":25,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Wuhan Createrna Science and Technology Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MY008211A tablets","EXPERIMENTAL","MY008211A tablets 400mg BID",[13],"Drug: MY008211A tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Eculizumab","ACTIVE_COMPARATOR","Eculizumab Injection",[19],"Drug: Eculizumab Injection",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Eculizumab Injection for 24 weeks",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Wuhan Createrna Science and Technology Co.,Ltd","CONTACT","027-68788900","+86","lcyxzx@createrna.com",[37,56],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100032","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":54,"phoneExt":25,"email":55},"Bing Han, PhD","010-69155027","Hanbing_Li@sina.com.cn",{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":43,"countryCode":44,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Chinese Academy of Medical Sciences Hematology Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020",{"type":46,"coordinates":63},[64,65],117.17667,39.14222,{"lat":65,"lon":64},[68],{"name":69,"role":32,"phone":70,"phoneExt":25,"email":25},"Fengkui Zhang, PhD","022-23909095",{"type":72,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100587773","phase-3-study-of-safety-and-efficacy-of-my008211a-in-paroxysmal-nocturnal-hemoglobinuria-pnh-patients-who-are-naive-to-complement-inhibitor-therapy-100587773",false,"NCT06932744","Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy","A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of MY008211A Tablets in PNH Patients Who Are Naive to Complement Inhibitor Therapy","Inclusion Criteria:\n\n1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg\u002Fm2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.\n2. Mean hemoglobin level \\\u003C100 g\u002FL at screening.\n3. LDH \\> 1.5 x Upper Limit of Normal (ULN) at screening.\n4. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.\n\nExclusion Criteria:\n\n1. Patients with reticulocytes \\\u003C100x10\\^9\u002FL; platelets \\\u003C30x10\\^9\u002FL; neutrophils \\\u003C0.5x10\\^9\u002FL.\n2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.\n3. Known or suspected hereditary complement deficiency.\n4. Previous bone marrow or hematopoietic stem cell transplantation.\n5. Previous splenectomy.\n6. A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.","ALL","18 Years","75 Years",{"count":84,"type":85},66,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.",[91],"Paroxysmal Nocturnal Haemoglobinuria (PNH)","2025-05-05",{"date":94,"type":95},"2025-05-09","ACTUAL",{"date":97,"type":95},"2024-08-30",{"date":99,"type":85},"2025-12-30",{"name":5,"class":6},2]