[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05796440":3,"trial-entities:NCT05796440":140,"trial-summary:NCT05796440":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":45,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":75,"locations":77,"central_contacts":136,"overall_officials":137,"references":138,"see_also_links":139},"NCT05796440","LUM-201-02","A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)","An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency","ENROLLING_BY_INVITATION","2028-04","2024-02","2024-02-15","2023-08-01","Lumos Pharma","INDUSTRY",false,"This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.","An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years.\n\nThere are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.",[19],"Growth Hormone Deficiency",[21,22,23,24,25,26],"LUM-201","PGHD","GHD","Growth hormone secretagogue","Oral","Height","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},60,"ESTIMATED",[35],{"type":36,"name":21,"description":37,"armGroupLabels":38},"DRUG","Administered orally once daily",[39],"LUM-201 (1.6 mg\u002Fkg\u002Fday)",[41],{"measure":42,"description":43,"timeFrame":44},"Incidence of treatment-emergent adverse events","Number of events","Day 1 to Month 36",[46,49,52,55,58,61],{"measure":47,"description":48,"timeFrame":44},"Growth Hormone Concentrations in subjects","Serum GH concentration",{"measure":50,"description":51,"timeFrame":44},"Insulin-like growth factor 1 concentration","Serum concentrations of insulin-like growth factor 1",{"measure":53,"description":54,"timeFrame":44},"Height standard deviation score (SDS)","Change in HT-SDS",{"measure":56,"description":57,"timeFrame":44},"Change in Weight SDS","Change in Weight",{"measure":59,"description":60,"timeFrame":44},"Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg\u002Fkg of LUM-201","(AHV) measured as standing height with stadiometer",{"measure":62,"description":63,"timeFrame":44},"Change in Bone Age (BA)","Change in Bone Age (BA) compared to Chronological Age","ALL","5 Years","14 Years",{"inclusion":68,"exclusion":71,"raw_text":74},[69,70],"Parent\u002Fcaregiver must sign the informed consent, and the subject must sign the assent, as applicable.","Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met.",[72,73],"Medical or genetic condition that, in the opinion of the PI and\u002For MMs, adds unwarranted risk to the use of LUM-201","Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201. Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.","Inclusion Criteria:\n\n* Parent\u002Fcaregiver must sign the informed consent, and the subject must sign the assent, as applicable.\n* Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met.\n\nExclusion Criteria:\n\n* Medical or genetic condition that, in the opinion of the PI and\u002For MMs, adds unwarranted risk to the use of LUM-201\n* Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201. Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.",[76],"CHILD",[78,87,95,103,111,119,127],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"University of Iowa","Iowa City","Iowa","52242","United States",{"lat":85,"lon":86},41.66113,-91.53017,{"facility":88,"city":89,"state":90,"zip":91,"country":83,"geoPoint":92},"UMass Memorial Medical Center","Worcester","Massachusetts","01655",{"lat":93,"lon":94},42.26259,-71.80229,{"facility":96,"city":97,"state":98,"zip":99,"country":83,"geoPoint":100},"Children's Mercy Hospital","Kansas City","Missouri","64111",{"lat":101,"lon":102},39.09973,-94.57857,{"facility":104,"city":105,"state":106,"zip":107,"country":83,"geoPoint":108},"University of South Carolina","Charleston","South Carolina","29425",{"lat":109,"lon":110},32.77632,-79.93275,{"facility":112,"city":113,"state":114,"zip":115,"country":83,"geoPoint":116},"Texas Tech University Health Sciences Center","Amarillo","Texas","79106",{"lat":117,"lon":118},35.222,-101.8313,{"facility":120,"city":121,"state":122,"zip":123,"country":83,"geoPoint":124},"Seattle Children's Hospital","Seattle","Washington","98105",{"lat":125,"lon":126},47.60621,-122.33207,{"facility":128,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Canberra Hospital","Garran","Australian Capital Territory","2605","Australia",{"lat":134,"lon":135},-35.34206,149.10846,[],[],[],[],{"nct_id":4,"conditions":141,"biomarkers":143},[142],"Idiopathic growth hormone deficiency",[],{"nct_id":4,"found":15,"summary":145,"prompt_version":145},null]