[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mucopolysaccharidosis-type-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mucopolysaccharidosis-type-ii":26},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100455264","phase-2-a-multi-cohort-study-of-safety-efficacy-pk-and-pd-of-gnr-055-in-patients-with-mucopolysaccharidosis-type-ii-100455264",false,"NCT05208281","A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II","Multicenter, Open-Label, Multi-cohort Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Drug Product GNR 055 (JSC \"GENERIUM\", Russia) in Patients With Mucopolysaccharidosis Type II","Inclusion Criteria:\n\n* Signed inform consent;\n* Verified diagnosis of MPS II (Hunter syndrome);\n* Naïve patients or patients who have received standard ERT whit idursulfase products;\n* No contraindications for lumbar puncture as judged by the Investigator;\n* Willingness and ability to follow study procedures.\n\nExclusion Criteria:\n\n* Clinically pronounced hypersensitivity to ID2S or any other component of the drug product;\n* History of hematopoietic stem cell transplantation (HSCT) or bone marrow transplantation;\n* Implanted or external non-removable metal devices, a cardiac pacemaker, or other objects sensitive to the magnetic field that may pose a danger to both the wearer and the correct operation of magnetic resonance imaging (MRI) equipment;\n* Concomitant diseases and conditions that, in the Investigator's opinion, can put at risk the patient's safety during his\u002Fher participation in the study, or which will influence the safety data analysis in case of the disease\u002Fcondition exacerbation during the study.","MALE",{"count":18,"type":19},32,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE2","PHASE3","This is phase 2\u002F3 study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational product GNR-055 in MPS II (Hunter syndrome) patients of different age groups.",[26,27],"Mucopolysaccharidosis Type II","Metabolic Diseases",[29,30,27,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"Mucopolysaccharidosis type II","Cognitive Dysfunction","Lysosomal Storage Diseases","Neurocognitive Disorders","Metabolism, Inborn","Genetic Diseases, Inborn","Neurobehavioral Manifestations","Neurologic Manifestations","Genetic Diseases, X-Linked","Hunter syndrome","Iduronate-2-sulfatase","Modified I2S protein","Connective Tissue Diseases","Mental Disorders","Intellectual Disability","Nervous System Diseases","Heredodegenerative Disorders, Nervous System","Cognition Disorders","Mental Retardation, X-Linked","RECRUITING","2025-07-28",{"date":51,"type":52},"2025-07-30","ACTUAL",{"date":54,"type":52},"2021-11-30",{"date":56,"type":19},"2028-03",{"name":58,"class":59},"AO GENERIUM","INDUSTRY",5]