[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492574":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":35,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":35,"enrollmentInfo":72,"targetDuration":35,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":35,"overallStatus":48,"whyStopped":35,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Pharmacosmos A\u002FS","INDUSTRY",[8,14,17,20,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1a-1b","EXPERIMENTAL","SP-420 for 48 weeks",[13],"Drug: SP-420",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2a-2b",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Cohort 3a-3b",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"1c-1d",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"2c-2d",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"3c-3d",[13],[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","SP-420","Capsules for oral intake",[21,24,27,9,15,18],null,[37],{"name":38,"affiliation":5,"role":39},"Pharmacosmos Clinical and non-clinical Department","STUDY_DIRECTOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":35,"email":44},"CONTACT","+45 5948 5959","info@pharmacosmos.com",[46],{"facility":47,"status":48,"city":49,"state":35,"zip":35,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":35},"Pharmacosmos Investigational Site","RECRUITING","Copenhagen","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],12.56553,55.67594,{"lat":56,"lon":55},{"type":59,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[61],{"name":62,"class":6},"ICON plc","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":73,"type":74},90,"ESTIMATED","INTERVENTIONAL",[77],"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",[80,81],"Beta Thalassemia Major Anemia","Myelodysplastic Syndrome","2025-09-19",{"date":84,"type":85},"2025-09-24","ACTUAL",{"date":87,"type":85},"2023-09-04",{"date":89,"type":74},"2028-05",{"name":5,"class":6},1]