[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574613":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":18,"centralContacts":34,"locations":45,"responsibleParty":62,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":92,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"St. Justine's Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Patient starting hydroxyurea that will have PK sample procurements at different timpoints over a period of 12 months until HU-AUC shows MTD",[13],"Diagnostic Test: Pharmacokinetic based dosage change",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","NO_INTERVENTION","Patient starting hydroxuyrea that will be followed as per standard of care over a period of 12 months until MTD has been reached",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Group C","Patient will undergo one PK sample procurement to evaluate level of HU-AUC after 12 months of taking hydroxyurea.",[23],"Diagnostic Test: Pharmacokinetic dosing",[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":18},"DIAGNOSTIC_TEST","Pharmacokinetic based dosage change","This study will compare 2 groups of sickle cell patients that are receiving hydroxyurea. Group A will have an increase in their dosage based on the pharmacokinetic result over a period of 12 months and Group B will have an increase in their dosage based on the standard of care follow-up over a period of 12 months. The aim is to evaluate if the group A can reach MTD faster than than the Group B",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":18},"Pharmacokinetic dosing","Patient with sickle cell disease will undergo one pharmacokinetic test after taking 12 months of hydroxyurea to evaluate HU-AUC at that timepoint",[20],[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Yves Pastore, MD","CONTACT","514-345-4931","5027","yves.pastore.med@ssss.gouv.qc.ca",{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},"Bianka Courcelle, Research nurse, RN","3757","bianka.courcelle.hsj@ssss.gouv.qc.ca",[46],{"facility":47,"status":18,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CHU Sainte-Justine","Montreal","Quebec","H3T 1C5","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-73.58781,45.50884,{"lat":57,"lon":56},[60],{"name":18,"role":37,"phone":61,"phoneExt":18,"email":44},"5146090420",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Yves Pastore","Co-director Sickle Cell Programm, Principal Investigator",[67],{"name":5,"class":6},"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":79,"type":80},29,"ESTIMATED","INTERVENTIONAL",[83,84],"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.",[87],"Sickle Cell Disease (SCD)",[89,90,91],"hydroxyurea","pharmacokinetic","sickle cell disease","NOT_YET_RECRUITING","2025-01-05",{"date":95,"type":96},"2025-01-07","ACTUAL",{"date":98,"type":80},"2025-01-15",{"date":100,"type":80},"2027-11-25",{"name":64,"class":6},1]