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Kingdom","UK",{"type":51,"coordinates":1026},[1027,1028],-3.18,51.48,{"lat":1028,"lon":1027},{"facility":1031,"status":44,"city":1032,"state":30,"zip":1022,"country":1023,"countryCode":1024,"cosmosGeoPoint":1033,"geoPoint":1037,"contacts":30},"Cardiff And Vale University Health Board","London",{"type":51,"coordinates":1034},[1035,1036],-0.12574,51.50853,{"lat":1036,"lon":1035},{"facility":1039,"status":44,"city":1032,"state":30,"zip":1040,"country":1023,"countryCode":1024,"cosmosGeoPoint":1041,"geoPoint":1043,"contacts":30},"Royal Free London Nhs Foundation Trust Royal Free Hospital","NW3 2QG",{"type":51,"coordinates":1042},[1035,1036],{"lat":1036,"lon":1035},{"facility":1045,"status":44,"city":1032,"state":30,"zip":1046,"country":1023,"countryCode":1024,"cosmosGeoPoint":1047,"geoPoint":1049,"contacts":30},"King's College Hospital","SE5 9RS",{"type":51,"coordinates":1048},[1035,1036],{"lat":1036,"lon":1035},{"facility":1051,"status":44,"city":1032,"state":30,"zip":1052,"country":1023,"countryCode":1024,"cosmosGeoPoint":1053,"geoPoint":1055,"contacts":30},"Imperial College Healthcare Nhs Trust - Hammersmith Hospital","W12 0HS",{"type":51,"coordinates":1054},[1035,1036],{"lat":1036,"lon":1035},{"facility":1057,"status":44,"city":1032,"state":30,"zip":1058,"country":1023,"countryCode":1024,"cosmosGeoPoint":1059,"geoPoint":1061,"contacts":30},"Great Ormond street Hospital for Children NHS Trust","WC1N 1DZ",{"type":51,"coordinates":1060},[1035,1036],{"lat":1036,"lon":1035},{"type":1063,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100520417","phase-3-a-study-of-mavorixafor-in-participants-with-congenital-and-acquired-primary-autoimmune-and-idiopathic-chronic-neutropenic-disorders-who-are-experiencing-recurrent-andor-serious-infections-100520417",false,"NCT06056297","A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and\u002For Serious Infections","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and\u002For Serious Infections","Key Inclusion Criteria:\n\n* Diagnosis of congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorder ≥6 months prior to the screening visit that is not attributable to medications, active or recent infections or malignancy.\n* Congenital Neutropenia, including but not limited to these classifications:\n\n  1. Isolated with a permanent (non-cyclic) presentation, for example, elastase, neutrophil expressed (ELANE), colony stimulating factor 3 receptor (CSF3R), C-X-C chemokine receptor 2 (CXCR2), Wiskott-Aldrich syndrome (WAS)\n  2. Associated with extra-hematologic manifestations, for example, Barth syndrome, Cohen syndrome, glucose-6-phosphatase catalytic subunit 3 (G6PC3), Kostmann disease\n  3. Associated with metabolic disorders, for example, glycogen storage disease 1b (GSD1b)\n  4. Shwachman-Diamond syndrome\n* Acquired Primary Neutropenia\n\n  1. Chronic idiopathic neutropenia\n  2. Primary autoimmune neutropenia. Other chronic neutropenia (CN) disorders that may be eligible for enrollment can be clarified and approved upon discussion with study Medical Monitor.\n* Have an ANC \\\u003C1000 cells\u002FµL during screening (single ANC value from hematology) and confirmed trough mean ANC (mean value of multiple ANC measurements over 6 hours) at baseline visit, with no clinical evidence of systemic infection.\n* Prior history of recurrent and\u002For serious infections during the 12 months preceding the screening visit (that is, suffering sequelae of chronic neutropenia), as defined by having at least 2 infections in the last 12 months that meet the following criteria:\n* Infection requiring the use of antibiotics (intravenous \\[IV\\]\u002Foral); OR\n* Infection requiring a visit to healthcare facility (including but not limited to emergency room visit, urgent care facility, primary care physician's office, or in-patient hospitalization);\n\nAND for all potential participants:\n\n* Infections considered by the Investigator to be likely related to the potential participant's CN disorder.\n* Participants who are on G-CSF or other active background therapy must have been receiving these therapies during the previous 12 months while continuing to suffer from infections, be on a stable dose and dosing schedule for ≥4 weeks prior to screening visit and remain on this dose and dosing schedule throughout the study (unless ANC \\>10,000 cells\u002FµL for ≥4 weeks).\n* Participants must be willing to keep their G-CSF or other background therapy doses\u002Fregimens stable (other than for safety reasons) for the duration of the study.\n\nKey Exclusion Criteria:\n\n* A diagnosis of secondary neutropenia including those due to:\n\n  1. Hypersplenism\n  2. Infection\n  3. Malignancy\n  4. Autoimmune disease, for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, graft-versus-host disease, thyroid disease\n  5. Nutritional deficiency, for example, vitamin B12, folic acid, copper, caloric malnutrition\n  6. Drug-induced cause, for example, chemotherapy, clozapine, antiretrovirals, antibiotics, monoclonal antibodies.\n* A diagnosis of any of the following:\n\n  1. Aplastic anemia\n  2. Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome\n  3. Certain CNs, including but not limited to these classifications are excluded:\n\n     1. Isolated with a cyclic presentation, for example, elastase, neutrophil expressed (ELANE)\n     2. Associated with immune dysregulation, for example, common variable immunodeficiency (CVID), autoimmune lymphoproliferative syndrome (ALPS), familial hemophagocytic lymphohistiocytosis, Chédiak-Higashi syndrome, GATA-binding protein 2 (GATA2) deficiency syndrome\n     3. Associated with bone marrow failure, for example, Fanconi anemia, Diamond-Blackfan anemia\n  4. Neutropenia associated with a Duffy-null phenotype (formerly known as benign ethnic neutropenia). However, a participant with an autosomal dominant pathogenic variant in a gene associated with CN on a Duffy-null background may be eligible for inclusion\n* A medical or personal condition that may potentially compromise the safety of the participant, may preclude the participant's successful completion of the clinical study, or could, in the opinion of the Investigator or the Medical Monitor, interfere with the objectives of the study.\n* Received more than 1 dose of mavorixafor in the past.\n* Received C-X-C chemokine receptor 4 (CXCR4) antagonist (other than mavorixafor) in the past 6 months.\n* Participants taking pegylated-G-CSF unless they have a diagnosis of congenital neutropenia confirmed at screening.\n* Participant is currently taking or has taken other investigational drug \\\u003C30 days prior to the screening visit or 5 half-lives, whichever is longer.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","ALL","12 Years",{"count":1074,"type":1075},176,"ESTIMATED","INTERVENTIONAL",[1078],"PHASE3","The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and\u002For serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.",[1081],"Neutropenia",[9,1083,1084,1085,1086,1087,1088,1089,1090,1091,1092,1093,1094,1095,1096],"Chronic neutropenia","Chronic idiopathic neutropenia","Severe Congenital Neutropenia (SCN)","C-X-C chemokine receptor 4 (CXCR4)","Congenital and acquired neutropenia","Autoimmune disease","Cohen syndrome","Barth syndrome","ELANE","G6PC3","GSD1b","Kostmann disease","Shwachman-Diamond syndrome","Autoimmune neutropenia (AIN)","2026-06-04",{"date":1099,"type":1100},"2026-06-05","ACTUAL",{"date":1102,"type":1100},"2024-06-06",{"date":1104,"type":1075},"2027-11",{"name":5,"class":6},114]