[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"beta-thalassemia-major-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:beta-thalassemia-major-anemia":26},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100492574","phase-2-a-trial-testing-sp-420-in-subjects-with-transfusion-dependent--thalassemia-or-low-risk-myelodysplastic-syndromes-100492574",false,"NCT05693909","A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes","An Open-label, Dose-escalation, Dose-finding, and Proof-of-concept Trial of SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes","Thalassemia cohorts:\n\nInclusion criteria:\n\n* Women and men aged 18 years or older\n* Transfusion-dependent β-thalassemia including HbE\u002Fβ-thalassemia requiring iron chelation therapy (β-thalassemia with mutation and\u002For multiplication of α-globin is allowed)\n* On a stable dose of iron chelation for at least 4 weeks prior to screening\n* Weight ≥ 35kg at screening\n* Transfusion iron overload\n* Treated and followed for at least the past 6 months in a specialized centre\n\nExclusion criteria:\n\n* β-thalassemia with the structural Hb variants HbS and HbC\n* Current MDS\n* Current biliary disorder\n* Historic or ongoing clinically significant kidney disease\n* Unable to undergo trial assessments including MRI e.g. due to claustrophobia in MRI scanner\n* Pregnant or nursing women\n* Men who do not agree to practice effective barrier contraception during the entire period\n\nMyelodysplastic Syndromes Cohorts:\n\nInclusion criteria:\n\n* Women and men aged 18 years or older\n* Very low, low, or intermediate risk Myelodysplastic Syndrome according to IPSS-R\n* Weight ≥ 35kg at screening\n* Transfusion iron overload\n* Treated and followed for at least the past 6 months at medical facilities experienced with MDS\n\nExclusion criteria:\n\n* Therapy-related MDS or MDS with a known bone marrow fibrosis\n* Diagnosis of decompensated liver cirrhosis\n* Clinically significant kidney disease, either historic or ongoing\n* Uncontrolled ischemic heart disease or uncontrolled arrythmia\n* Uncontrolled hypertension\n* Uncontrolled dyslipidaemia\n* Uncontrolled Diabetes\n* Major surgery within 8 weeks prior to screening\n* Pregnant or nursing women\n* Men who do not agree to practice effective barrier contraception during the entire period","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn about SP-420 ability to remove iron from organs in subjects with transfusion-dependent β-thalassemia or transfusion-dependent low-risk myelodysplastic syndrome.\n\nThe main questions it aims to answer are:\n\n* How efficient is SP-420 in cleaning iron from the liver?\n* How is the safety and tolerability of ascending doses of SP-420?\n\nParticipants will:\n\n* Take medication three times weekly\n* Attend up to 20 site visits\n* Undergo MRI scans",[26,27],"Beta Thalassemia Major Anemia","Myelodysplastic Syndrome","RECRUITING","2025-09-19",{"date":31,"type":32},"2025-09-24","ACTUAL",{"date":34,"type":32},"2023-09-04",{"date":36,"type":20},"2028-05",{"name":38,"class":39},"Pharmacosmos A\u002FS","INDUSTRY"]