[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07393373":3,"trial-entities:NCT07393373":308,"trial-summary:NCT07393373":314},{"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":44,"primary_purpose":45,"phases":46,"enrollment_info":48,"interventions":51,"primary_outcomes":58,"secondary_outcomes":64,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":107,"locations":110,"central_contacts":301,"overall_officials":302,"references":306,"see_also_links":307},"NCT07393373","QBGJ398-205","Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia","Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Hypochondroplasia: ACCEL OLE","ENROLLING_BY_INVITATION","2036-05-31","2026-05","2026-05-26","2026-04-23","QED Therapeutics, a BridgeBio company","INDUSTRY",true,"Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with Hypochondroplasia (HCH) who previously completed ACCEL 2\u002F3, and potentially additional participants who completed ACCEL. Participants rolling over directly from the observational ACCEL study must have had at least a 6-month period of growth assessment in that study.",null,[19],"Hypochondroplasia",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"skeletal dysplasia","endochondral ossification","hypochondroplasia","HCH","shortened proximal limbs","fibroblast growth factor receptor 3","FGFR3","endochondral bone formation","disproportionate short stature","quality of life","dwarfism","bone diseases","musculoskeletal diseases","osteochondrodysplasia","functional abilities","annualized growth velocity","annualized height velocity","growth","genetic diseases","congenital","AHV","AGV","Pathogenic variants","INTERVENTIONAL","TREATMENT",[47],"PHASE2",{"count":49,"type":50},135,"ESTIMATED",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56},"DRUG","Infigratinib","Infigratinib to be administered by mouth and initiated at the last dose level received in the ACCEL 2\u002F3 study or at the dose selected to be further evaluated after proof-of-concept is established for Phase 2 portion of ACCEL 2\u002F3.",[57],"Arm 1: Rollover subjects",[59,62],{"measure":60,"timeFrame":61},"Incidence of treatment emergent adverse events (TEAE) and serious TEAE","10 years",{"measure":63,"timeFrame":61},"Changes over time in standing height Z-score in relation to HCH and non-HCH growth charts",[65,67,69,71,73,75,77,79,81,83,85,87,89,91,93,95,97],{"measure":66,"timeFrame":61},"Changes over time in AHV Z-score",{"measure":68,"timeFrame":61},"Changes over time in body proportions",{"measure":70,"timeFrame":61},"Changes over time in weight Z-score",{"measure":72,"timeFrame":61},"Changes overtime in BMI",{"measure":74,"timeFrame":61},"Age of puberty onset and time to Tanner stage ≥4",{"measure":76,"timeFrame":61},"Changes over time in body composition as assessed by DXA (dual x-ray absorptiometry) scans",{"measure":78,"timeFrame":61},"Changes over time in bone morphology\u002Fdensity by x-ray and DXA",{"measure":80,"timeFrame":61},"Change in psychomotor function assessed by age-appropriate computerized tests (Detection Test)",{"measure":82,"timeFrame":61},"Change in attention assessed by age-appropriate computerized tests (Identification Test)",{"measure":84,"timeFrame":61},"Change in visual learning assessed by age-appropriate computerized tests (One Card Learning Test)",{"measure":86,"timeFrame":61},"Change in working memory assessed by age-appropriate computerized tests (One Back Test)",{"measure":88,"timeFrame":61},"Changes over time in severity of epilepsy measured by frequency and adverse event grading",{"measure":90,"timeFrame":61},"Changes in health-related Quality of life [HRQoL] as assessed by Pediatric Quality of Life Inventory (PedsQL)",{"measure":92,"timeFrame":61},"Changes in health-related Quality of life [HRQoL] as assessed by Quality of Life in Short Stature Youth questionnaire (QoLISSY)",{"measure":94,"timeFrame":61},"Severity of the physical functioning challenges as assessed by Patient\u002FParent Global Impression of Severity (PGI-S)",{"measure":96,"timeFrame":61},"Severity of the physical functioning challenges as assessed by Patient\u002FParent Global Impression of Change (PGI-C)",{"measure":98,"timeFrame":61},"Subject and caregiver evaluation of treatment benefit as assessed by a qualitative interview","ALL","3 Years","18 Years",false,{"inclusion":104,"exclusion":105,"raw_text":106},[],[],"Inclusion Criteria:\n\n* Inclusion Criteria for Participants Rolling Over from ACCEL 2\u002F3\n\n  1. Pediatric participants with HCH who have completed ACCEL 2\u002F3\n  2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche\n\nExclusion Criteria:\n\n* Exclusion Criteria for Participants Rolling Over from ACCEL 2\u002F3\n\n  1. Participant has concurrent medical condition that, in the view of the PI and\u002For sponsor, would interfere with study participation or safety evaluations\n  2. Participants who developed a medical condition that requires the initiation of treatment with a prohibited medication\n  3. Participants who prematurely discontinued ACCEL 2\u002F3\n  4. Participants who have reached final height or near final height\n  5. Current participation in an ongoing clinical study with a sponsor other than QED",[108,109],"CHILD","ADULT",[111,120,128,136,144,152,160,168,176,185,194,201,209,217,224,231,239,246,254,261,269,277,286,293],{"facility":112,"city":113,"state":114,"zip":115,"country":116,"geoPoint":117},"UCSF Benioff Children's Hospital","Oakland","California","94609","United States",{"lat":118,"lon":119},37.80437,-122.2708,{"facility":121,"city":122,"state":123,"zip":124,"country":116,"geoPoint":125},"Childrens Hospital Colorado","Aurora","Colorado","80045",{"lat":126,"lon":127},39.72943,-104.83192,{"facility":129,"city":130,"state":131,"zip":132,"country":116,"geoPoint":133},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"lat":134,"lon":135},38.89511,-77.03637,{"facility":137,"city":138,"state":139,"zip":140,"country":116,"geoPoint":141},"Johns Hopkins School of Medicine","Baltimore","Maryland","21287",{"lat":142,"lon":143},39.29038,-76.61219,{"facility":145,"city":146,"state":147,"zip":148,"country":116,"geoPoint":149},"University of Missouri","Columbia","Missouri","65201",{"lat":150,"lon":151},38.95171,-92.33407,{"facility":153,"city":154,"state":155,"zip":156,"country":116,"geoPoint":157},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"lat":158,"lon":159},39.12711,-84.51439,{"facility":161,"city":162,"state":163,"zip":164,"country":116,"geoPoint":165},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"lat":166,"lon":167},36.16589,-86.78444,{"facility":169,"city":170,"state":171,"zip":172,"country":116,"geoPoint":173},"University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic","Madison","Wisconsin","53705",{"lat":174,"lon":175},43.07305,-89.40123,{"facility":177,"city":178,"state":179,"zip":180,"country":181,"geoPoint":182},"Murdoch Children's Research Institute - The Royal Children's Hospital Melbourne","Parkville","Victoria","3052","Australia",{"lat":183,"lon":184},-37.78333,144.95,{"facility":186,"city":187,"state":188,"zip":189,"country":190,"geoPoint":191},"London Health Sciences Centre - Children's Hospital of Western Ontario","London","Ontario","N6C 2R5","Canada",{"lat":192,"lon":193},42.98339,-81.23304,{"facility":195,"city":196,"state":188,"zip":197,"country":190,"geoPoint":198},"Children's Hospital of Eastern Ontario Research Institute","Ottawa","K1H 8L1",{"lat":199,"lon":200},45.41117,-75.69812,{"facility":202,"city":203,"state":204,"zip":205,"country":190,"geoPoint":206},"Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine","Montreal","Quebec","H3T 1C5",{"lat":207,"lon":208},45.50884,-73.58781,{"facility":210,"city":211,"zip":212,"country":213,"geoPoint":214},"Hôpital Femme Mère Enfant","Bron","69677","France",{"lat":215,"lon":216},45.73865,4.91303,{"facility":218,"city":219,"zip":220,"country":213,"geoPoint":221},"Hôpital Universitaire Necker-Enfants Malades","Paris","75015",{"lat":222,"lon":223},48.85341,2.3488,{"facility":225,"city":226,"zip":227,"country":213,"geoPoint":228},"Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants","Toulouse","31059",{"lat":229,"lon":230},43.60426,1.44367,{"facility":232,"city":233,"zip":234,"country":235,"geoPoint":236},"Haukeland University Hospital","Bergen","5021","Norway",{"lat":237,"lon":238},60.39299,5.32415,{"facility":240,"city":241,"zip":242,"country":235,"geoPoint":243},"Paediatric Clinical Research Unit at Oslo University Hospital","Oslo","0372",{"lat":244,"lon":245},59.91273,10.74609,{"facility":247,"city":248,"zip":249,"country":250,"geoPoint":251},"Hospital Pediátrico de Coimbra","Coimbra","3000-602","Portugal",{"lat":252,"lon":253},40.20686,-8.41996,{"facility":255,"city":256,"zip":257,"country":256,"geoPoint":258},"KK Women's and Children's Hospital","Singapore","229899",{"lat":259,"lon":260},1.28967,103.85007,{"facility":262,"city":263,"zip":264,"country":265,"geoPoint":266},"Unidad de Cirugía Artroscopica, Hopsital MIKS","Vitoria-Gasteiz","01010","Spain",{"lat":267,"lon":268},42.84998,-2.67268,{"facility":270,"city":271,"zip":272,"country":273,"geoPoint":274},"Astrid Lindgren Children's Hospital","Solna","17164","Sweden",{"lat":275,"lon":276},59.36004,18.00086,{"facility":278,"city":279,"state":280,"zip":281,"country":282,"geoPoint":283},"Manchester University","Manchester","England","M13 9WL","United Kingdom",{"lat":284,"lon":285},53.48095,-2.23743,{"facility":287,"city":288,"state":280,"zip":289,"country":282,"geoPoint":290},"Sheffield Children's Hospital","Sheffield","S10 2TH",{"lat":291,"lon":292},53.38297,-1.4659,{"facility":294,"city":295,"state":296,"zip":297,"country":282,"geoPoint":298},"Glasgow Clinical Research Facility, Queen Elizabeth University Hospital","Glasgow","Scotland","G51 4TF",{"lat":299,"lon":300},55.86515,-4.25763,[],[303],{"name":304,"affiliation":13,"role":305},"QED Therapeutics SVP, Clinical Development","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":309,"biomarkers":310},[19],[311,312,313],"FGFR1 Gene","Fibroblast Growth Factor Receptor 2","Fibroblast Growth Factor Receptor 3",{"nct_id":4,"found":102,"summary":17,"prompt_version":17}]