[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556030":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":33,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":18,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin group","EXPERIMENTAL","Patients will receive metformin immediate-release tablets orally for 24 weeks. Starting dose will be 500 mg once daily for all patients and the dose will be increased by 500 mg weekly until the goal dose is achieved (500 mg twice daily for patients \\\u003C 10 years of age, and 1000 mg twice daily for patients 10 years or older).",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Other treatment group","NO_INTERVENTION","Patients will receive supportive treatment as indicated",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Metformin","Patients will receive metformin immediate-release tablets orally for 24 weeks. Starting dose will be 500 mg once daily for all patients and the dose will be increased by 500 mg weekly until the goal dose is achieved (500 mg twice daily for patients \\\u003C 10 years of age, and 1000 mg twice daily for patients 10 years or older)",[9],[26],"Glucophage",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Sara M Makkeyah, MD","CONTACT","+201140105222","smakkeyah@med.asu.edu.eg",[34,46],{"facility":35,"status":36,"city":37,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":18},"University of Alexandria","RECRUITING","Alexandria","Egypt","EG",{"type":41,"coordinates":42},"Point",[43,44],29.91582,31.20176,{"lat":44,"lon":43},{"facility":5,"status":36,"city":47,"state":18,"zip":48,"country":38,"countryCode":39,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Cairo","11566",{"type":41,"coordinates":50},[51,52],31.24967,30.06263,{"lat":52,"lon":51},[55],{"name":29,"role":30,"phone":56,"phoneExt":18,"email":32},"01140105222",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100556030","phase-3-safety-and-efficacy-of-metformin-for-treatment-of-cytopenia-in-children-and-adolescents-with-fanconi-anemia-100556030",false,"NCT06519786","Safety and Efficacy of Metformin for Treatment of Cytopenia in Children and Adolescents With Fanconi Anemia","Inclusion Criteria:\n\n* Age: 5 to 18 years\n* Patients who are diagnosed with Fanconi anemia based on clinical features and confirmed by increased chromosomal breakage on diepoxybutane (DEB) stress testing.\n* Presence of cytopenia (at least one of the following: hemoglobin (Hb) \\\u003C 10 g\u002FdL, platelet count \\\u003C 100 x 109\u002FL, or an absolute neutrophil count (ANC) \\\u003C 1.0 x 109\u002FL\n* Patients receiving other therapies e.g., androgens are eligible for enrollment after a one-month washout period before the start of metformin.\n\nExclusion Criteria:\n\n* Patients who underwent bone marrow transplantation.\n* Patients with evidence of myelodysplasia, leukemia, or other concurrent malignancy.\n* Patients who have a history of allergic reactions to metformin or similar compounds.\n* Patients with a history of symptomatic hypoglycemia over the past year or hypoglycemia \\\u003C 50 mg\u002FdL on screening and baseline laboratory assessments.\n* Patients with type 1 diabetes mellitus.\n* Patients with vitamin B12 deficiency.\n* Patients with Glucose-6-Phosphate Dehydrogenase deficiency.\n* Patients with abnormal Kidney function tests including serum creatinine, elevated liver function tests including live enzymes (ALT or AST \\> 135 U\u002FL, total bilirubin \\> 1.5 x upper limit of normal for age, and\u002For patients with metabolic acidosis (bicarbonate \\\u003C 17 meq\u002FL on venous blood gases).","ALL","5 Years","18 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","Prospective interventional open-label non-randomized controlled trial to assess safety and efficacy of metformin in treating cytopenia in children and adolescents with Fanconi Anemia.",[76],"Fanconi Anemia","UNKNOWN","2024-07-20",{"date":80,"type":81},"2024-07-25","ACTUAL",{"date":83,"type":81},"2022-10-05",{"date":85,"type":70},"2025-03",{"name":5,"class":6},2]