[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yves Pastore\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100574613","phase-2-optimizing-hydroxyurea-dosage-with-pharmakokinetic-in-patients-suffering-of-moderate-to-severe-sickle-cell-anemia-100574613",false,"NCT06761560","Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia","OPTIMA","Inclusion Criteria (Group A and B) :\n\n* Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.\n* Be patients with SS, SBThal0.\n* Agree to take hydroxyurea for a period of 12 months\n* Be between age of 6months old and 18 years old.\n* Have consented for participation in the study.\n\nInclusion Criteria (Group C) :\n\n* Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.\n* Be patients with SS, SBThal0.\n* Have taken hydroxyurea for a period of at least 12 months, and have received HU at a stable dose and at MTD for at least 6 months.\n* Be between age of 6months old and 18 years old.\n* Have consented for participation in the study.\n\nExclusion Criteria:\n\n* Patients with sickle cell genotype other than SS or SBThal0 (SC, SBThal+, SE or SD)\n* Patients on chronic transfusion program\n* Patients have received a blood transfusion in the last 4 weeks of study enrollment.\n* Have received a hematopoietic stem-cell transplantation\n* Creatinine \\>2x normal for age\n* ALT\\>2x normal for age\n* Sexually active females unwilling to comply with reliable method of birth control\n* Pregnancy\n* Conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.","ALL","6 Months","18 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The goal of this study is to evaluate if patients with sickle cell disease can achieve a maximum tolerate dose of hydroxuyrea (HU) over a period of 12 months faster with pharmacokinetic testing than the standard of care bloodwork follow-up. Pharmacokinetic test is used to evaluate the process by which drugs are absorbed, distributed in the body, localized in the tissues, and is excreted.\n\nPatient will be a randomized (coin toss method) into 2 groups. Group A will have an increase of their HU dosage with pharmacokinetic results and Group B will have an increase of their HU dosage following the standard of care bloodwork follow-up.\n\nGroup C will include patient with sickle cell disease that has been taking HU for at least 12 months and will undergo a pharmacokinetic dosage to check the level of HU only one time.",[28],"Sickle Cell Disease (SCD)",[30,31,32],"hydroxyurea","pharmacokinetic","sickle cell disease","NOT_YET_RECRUITING","2025-01-05",{"date":36,"type":37},"2025-01-07","ACTUAL",{"date":39,"type":21},"2025-01-15",{"date":41,"type":21},"2027-11-25",{"name":43,"class":44},"Yves Pastore","OTHER",""]