[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587773":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":56,"overallOfficials":35,"centralContacts":64,"locations":71,"responsibleParty":106,"collaborators":35,"id":108,"slug":35,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":35,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":35,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":35,"overallStatus":93,"whyStopped":35,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Wuhan Createrna Science and Technology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"The proportion of Participants With Sustained Hemoglobin Levels of ≥ 120 g\u002FL in the Absence of Red Blood Cell Transfusions","The proportion of patients with sustained hemoglobin levels ≥ 120 g\u002FL among those without RBC transfusion (defined as no red blood cell infusion after D14 to D168).","between Day 126 and Day 168",[14,17,20,22,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"The proportion of subjects with an increase in hemoglobin concentration ≥ 20 g\u002FL from baseline among subjects who do not receive RBC transfusion","Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥ 20 g\u002FL assessed among those without RBC transfusion (defined as no red blood cell infusion after D14 to D168).",{"measure":18,"description":19,"timeFrame":12},"The proportion of patients with LDH \u003C 1.5 ULN among those without RBC transfusion.","The proportion of patients with hemolysis controlled (defined as LDH \\\u003C 1.5 ULN) among those without RBC transfusion",{"measure":21,"description":21,"timeFrame":12},"Change (Expressed as Percentages) in LDH level from baseline",{"measure":23,"description":23,"timeFrame":12},"Change in reticulocyte count from baseline",{"measure":25,"description":25,"timeFrame":26},"The proportion of patients without RBC transfusion","between Day 14 and Day 168",{"measure":28,"description":29,"timeFrame":12},"Change in FACIT-F score from baseline","Change from baseline in FACIT-Fatigue scores. The FACIT-Fatigue is a 13-item questionnaire with support for its validity and reliability in PNH that assesses patient self-reported fatigue and its impact on daily activities and function. All FACIT scales are scored so that a high score is better. As each of the 13 items of the FACIT-F Scale ranges from 0-4, the range of possible scores is 0-52, with 0 being the worst possible score and 52 the best.",{"measure":31,"description":31,"timeFrame":32},"The Clinical BTH Rate","between Day 1 and Day 168",{"measure":34,"description":34,"timeFrame":32},"The Major Adverse Vascular Events Rate",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","This is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this study is to determine whether MY008211A compared to eculizumab is efficacious and safe for the treatment of PNH patients who were naive to complement inhibitor therapy.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"MY008211A tablets","EXPERIMENTAL","MY008211A tablets 400mg BID",[49],"Drug: MY008211A tablets",{"label":51,"type":52,"description":53,"interventionNames":54},"Eculizumab","ACTIVE_COMPARATOR","Eculizumab Injection",[55],"Drug: Eculizumab Injection",[57,61],{"type":58,"name":45,"description":59,"armGroupLabels":60,"otherNames":35},"DRUG","Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks",[45],{"type":58,"name":53,"description":62,"armGroupLabels":63,"otherNames":35},"Eculizumab Injection for 24 weeks",[51],[65],{"name":66,"role":67,"phone":68,"phoneExt":69,"email":70},"Wuhan Createrna Science and Technology Co.,Ltd","CONTACT","027-68788900","+86","lcyxzx@createrna.com",[72,91],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100032","China","CN",{"type":81,"coordinates":82},"Point",[83,84],116.39723,39.9075,{"lat":84,"lon":83},[87],{"name":88,"role":67,"phone":89,"phoneExt":35,"email":90},"Bing Han, PhD","010-69155027","Hanbing_Li@sina.com.cn",{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":78,"countryCode":79,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Chinese Academy of Medical Sciences Hematology Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020",{"type":81,"coordinates":98},[99,100],117.17667,39.14222,{"lat":100,"lon":99},[103],{"name":104,"role":67,"phone":105,"phoneExt":35,"email":35},"Fengkui Zhang, PhD","022-23909095",{"type":107,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":118,"type":119},66,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.",[125],"Paroxysmal Nocturnal Haemoglobinuria (PNH)","2025-05-05",{"date":128,"type":129},"2025-05-09","ACTUAL",{"date":131,"type":129},"2024-08-30",{"date":133,"type":119},"2025-12-30",{"name":5,"class":6},2]