[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pharmacosmos A\u002FS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":137},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,62,85,114],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100629319","phase-3-effect-of-trilaciclib-in-the-prevention-of-myelosupression-in-subjects-with-limited-stage-small-cell-lung-cancer-100629319",false,"NCT07473128","Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer","A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Confirmed diagnosis of Limited-Stage Small Cell Lung Cancer\n* Complete recovery from prior anti-tumor surgical procedures\n* Measurable and evaluable disease through tumor assessment\n* Willingness to participate and sign informed consent form\n\nExclusion Criteria:\n\n* Extensive Stage Small Cell Lung Cancer\n* Active cardiovascular disease\n* Known hypersensitivity to trilaciclib, etoposide, carboplatin, cisplatin or any component in their formulations\n* Pregnant or nursing women","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is:\n\nDoes trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer?\n\nParticipants will be randomised to receive either trilaciclib or placebo.",[26],"Limited Stage Small Cell Lung Cancer","RECRUITING","2026-06-15",{"date":30,"type":31},"2026-06-17","ACTUAL",{"date":33,"type":20},"2026-06-30",{"date":35,"type":20},"2027-06",{"name":37,"class":38},"Pharmacosmos A\u002FS","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100453031","phase-3-multi-center-trial-of-ferric-derisomaltose-in-children-0-to-18-years-of-age-with-iron-deficiency-anemia-100453031","NCT05179226","Multi-center Trial of Ferric Derisomaltose in Children 0 to \u003C18 Years of Age With Iron Deficiency Anemia","A Phase III, Prospective, Open-label, Multi-center Trial of Ferric Derisomaltose in Children 0 to \u003C18 Years of Age With Iron Deficiency Anemia Due to NDD-CKD or With Iron Deficiency Anemia Who Are Intolerant or Unresponsive to Oral Iron","Inclusion Criteria:\n\n* Subjects \\\u003C18 years\n* Informed consent and child assent, as age-appropriate, obtained before any trial- related activities and willingness to participate. LAR of the subject must sign and date the ICF (according to local requirements). The child must sign and date the CAF or provide oral assent, if required according to local requirements\n* IDA caused by different etiologies such as gastrointestinal disease, NDD-CKD, or other conditions leading to IDA\n* Hb concentration less than the 5th percentile for age and sex-specific reference range (Appendix B)\n* Subjects with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b):\n\n  a) Subjects with NDD-CKD:\n* TSAT ≤35 % or s-ferritin \\\u003C100 ng\u002FmL\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2\n* If on ESA, receiving stable ESA regimen defined as dose adjustments no more than\n\n  ± 20 % for ≥8 weeks prior to screening\n\n  b) Subjects with documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to trial enrolment.\n* TSAT ≤20 % or s-ferritin \\\u003C100 ng\u002FmL\n\nExclusion Criteria:\n\n* Anemia caused by factors other than IDA according to Investigator's judgment\n* S-ferritin \\>600 ng\u002FmL\n* Hb ≤5.0 g\u002FdL\n* Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)\n* ALAT and\u002For ASAT \\>2 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)\n* Pregnant or nursing female subjects. In order to avoid pregnancy, female subjects of childbearing potential have to use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) or be abstinent during the whole trial period and 7 days after the last dosing. Childbearing potential refers to all female subjects ≥12 years old or \\\u003C12 years old who have started menstruating\n* Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose\n* Received an investigational drug within 30 days prior to screening\n* Treatment with IV iron within 10 days prior to screening\n* Treatment with blood transfusion, radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 30 days prior to screening\n* Planned elective surgery (or planned surgery during the trial period) where significant blood loss is expected within the last 30 days prior to screening\n* Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)\n* Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements","17 Years",{"count":49,"type":20},200,[23],"Several clinical trials have been reported for ferric derisomaltose where it has been shown to be well tolerated and to improve markers of IDA. All clinical trials with ferric derisomaltose have been performed in adults, however, IDA is not specific to the adult population. In fact, children are likely to develop IDA due to their rapid growth.\n\nThe aim in this trial is to evaluate the efficacy and safety of intravenous (IV) ferric derisomaltose in children 0 to \\\u003C18 years of age with IDA due to NDD-CKD or with IDA who are intolerant or unresponsive to oral iron .\n\nThe subjects will receive ferric derisomaltose\u002Firon isomaltoside 1000 (Monoferric®\u002FMonofer®), at single doses of 10 mg\u002Fkg or 20 mg\u002Fkg with a maximal dose of 1000 mg.\n\n24 subjects will be part of a PK assessment, meaning that more blood samples will be drawn within the first week after treatment. The blood samples will be used for analysis of the amount of total iron in the blood from treatment is given to day 7.\n\nFor the individual subject, duration of the trial will be approximately 10 weeks (including a 14-day screening period) and each subject will attend 6-9 visits. Subjects who will be included in the PK assessments will attend 8 (subjects age 6 to \\\u003C12 years old and 0 to \\\u003C6 years old) or 9 (subjects age 12 to \\\u003C18 years old) visits, while the other subjects will attend 6 visits.",[53],"Iron Deficiency, Anaemia in Children","2026-04-09",{"date":56,"type":31},"2026-04-14",{"date":58,"type":31},"2022-11-28",{"date":60,"type":20},"2026-04-30",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":39},"100492574","phase-2-a-trial-testing-sp-420-in-subjects-with-transfusion-dependent--thalassemia-or-low-risk-myelodysplastic-syndromes-100492574","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",{"count":70,"type":20},90,[72],"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",[75,76],"Beta Thalassemia Major Anemia","Myelodysplastic Syndrome","2025-09-19",{"date":79,"type":31},"2025-09-24",{"date":81,"type":31},"2023-09-04",{"date":83,"type":20},"2028-05",{"name":37,"class":38},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":39},"100506439","phase-4-trilaciclib-vs-placebo-in-patients-with-extensive-stage-small-cell-lung-cancer-es-sclc-receiving-topotecan-100506439","NCT05874401","Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan","A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy","Inclusion Criteria:\n\n1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology\n2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.\n3. Measurable or evaluable disease as defined by RECIST v1.1\n\nExclusion Criteria:\n\n1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC\n2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer\n3. Presence of brain metastases\u002Fleptomeningeal disease requiring immediate treatment with radiation therapy or steroids\n4. Radiotherapy within 2 weeks\n5. History of ILD\u002Fpneumonitis\n6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers",{"count":93,"type":20},302,[95],"PHASE4","This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.",[98],"Extensive-stage Small-cell Lung Cancer",[100,101,102,103,104,105],"myelosuppression","ES-SCLC","chemotherapy-induced myelosuppression","chemotherapy-induced neutropenia","chemotherapy-induced anemia","myeloprotection","2025-08-27",{"date":108,"type":31},"2025-09-04",{"date":110,"type":31},"2023-10-18",{"date":112,"type":20},"2027-10-30",{"name":37,"class":38},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":39},"100587547","phase-3-multi-center-trial-of-ferric-derisomaltose-versus-no-intravenous-iron-in-iron-deficient-subjects-with-symptomatic-chronic-heart-failure-100587547","NCT06929806","Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure","A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure","ICONIC-HF","Inclusion Criteria:\n\n* 18 years or older\n* Both women and men can join\n* Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity\n* Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less\n* Have low iron levels in the blood\n* New York Heart Association (NYHA) Heart Failure Classification II, III or IV\n\nExclusion Criteria:\n\n* Planned cardiac surgery or revascularization or cardiac device implantation\n* Pregnant or nursing women\n* Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months\n* Treatment with radiotherapy or chemotherapy",{"count":123,"type":20},1900,[23],"The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is:\n\n• How many participants are admitted to the hospital or die from a disease in the heart or blood vessels\n\nResearchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.\n\nParticipants will:\n\n* Be randomized 50\u002F50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose\n* All participants receives standard of care\n* Visit site 4-5 times and have 7 video\u002Fphone-calls",[127,128],"Chronic Heart Failure","Iron Deficiencies","2025-07-17",{"date":131,"type":31},"2025-07-23",{"date":133,"type":31},"2025-05-01",{"date":135,"type":20},"2027-12-01",{"name":37,"class":38},""]