[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526413":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":26,"responsibleParty":33,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":26,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":26},{"fullName":5,"class":6},"Wuhan Createrna Science and Technology Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 MY008211A low dose","EXPERIMENTAL","Participants will receive MY008211A at a dose of 400 mg orally b.i.d",[13],"Drug: MY008211A tablets",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2 MY008211A high dose","Participants will receive MY008211A at a dose of 600 mg orally b.i.d",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","MY008211A tablets","dose 1 (400 mg BID) and dose 2 (600 mg BID) in a 1:1 ratio by central randomization",[9,15],[25],"MY008211A",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Xiaoni Li, Ph.D","CONTACT","021-51158605","lixiaoni@createrna.com",{"type":34,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100526413","phase-2-study-of-safety-and-efficacy-of-my008211a-in-in-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-100526413",false,"NCT06134414","Study of Safety and Efficacy of MY008211A in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","A Multi-center, Randomized, Parallel, Open-label Clinical Phase II Study, to Evaluate the Efficacy and Safety of MY008211A in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients With Signs of Active Hemolysis","Inclusion Criteria:\n\n* 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%.\n* Mean hemoglobin level \\\u003C100 g\u002FL.\n* LDH \\> 1.5 x Upper Limit of Normal (ULN).\n* 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\n* Patients with reticulocytes \\\u003C100x10\\^9\u002FL; platelets \\\u003C30x10\\^9\u002FL; neutrophils \\\u003C0.5x10\\^9\u002FL.\n* Were using a complement inhibitor before the first administration of MY008211A tablets or had discontinued a previous complement inhibitor for less than five half-lives or 120 days, whichever was the longest.\n* History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.\n* Known or suspected hereditary complement deficiency.\n* Previous bone marrow or hematopoietic stem cell transplantation.\n* Previous splenectomy.\n* 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":46,"type":47},40,"ESTIMATED","INTERVENTIONAL",[50],"PHASE2","The main purpose of this study is to evaluate the efficacy of MY008211A in adult patients with PNH, showing signs of active hemolysis.",[53],"Paroxysmal Nocturnal Hemoglobinuria (PNH)","NOT_YET_RECRUITING","2025-07-27",{"date":57,"type":58},"2025-07-29","ACTUAL",{"date":60,"type":47},"2025-12",{"date":62,"type":47},"2027-12",{"name":5,"class":6}]