[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bisirna Therapeutics (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100655691","phase-3-a-multicenter-randomized-open-label-positive-controlled-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-vsa012-injection-in-participants-with-paroxysmal-nocturnal-hemoglobinuria-who-are-naive-to-complement-inhibitor-therapy-100655691",false,"NCT07816237","A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy","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 at screening.\n* LDH \\> 1.5 x Upper Limit of Normal (ULN) at screening.\n* Vaccination against Neisseria meningitidis infection is required prior to the\n* start of study treatment. If not received previously, vaccination against\n* Streptococcus pneumoniae and Haemophilus influenzae infections should be given.\n\nExclusion Criteria:\n\n* Known or suspected hereditary or acquired complement deficiency;\n* Presence or suspicion of a systemic active bacterial, viral, or fungal infection\n* History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)\n* Patients with reticulocytes \\\u003C100x10\\^9\u002FL; platelets \\\u003C30x10\\^9\u002FL; neutrophils \\\u003C0.5x10\\^9\u002FL.\n* Positive of HIV, HBsAg or HCVAb.\n* History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.\n* Previous splenectomy.\n* A history of malignancy within 5 years before screening","ALL","18 Years","75 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.",[26],"Paroxysmal Nocturnal Hemoglobinuria, PNH","NOT_YET_RECRUITING","2026-09-09",{"date":30,"type":31},"2026-09-11","ACTUAL",{"date":33,"type":20},"2026-10-29",{"date":35,"type":20},"2029-12-31",{"name":37,"class":38},"Bisirna Therapeutics (Suzhou) Co., Ltd.","INDUSTRY",14,""]