[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618474":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":11,"studyPopulation":11,"armGroups":99,"interventions":116,"overallOfficials":11,"centralContacts":125,"locations":131,"responsibleParty":971,"collaborators":11,"id":973,"slug":11,"hasResults":974,"nctId":975,"briefTitle":976,"officialTitle":977,"acronym":11,"eligibilityCriteria":978,"healthyVolunteers":974,"sex":979,"minAge":980,"maxAge":11,"enrollmentInfo":981,"targetDuration":11,"studyType":984,"phases":985,"briefSummary":987,"conditions":988,"keywords":990,"overallStatus":164,"whyStopped":11,"lastUpdateSubmitDate":994,"lastUpdatePostDateStruct":995,"startDateStruct":998,"completionDateStruct":1000,"leadSponsor":1002,"locationsCount":1003},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC)",null,"At Baseline and Day 360",[14,17,19,21,23,27,29,32,34,36,39,42,45,47,50,53,57,60,63,66,69,72,75,77,79,82,84],{"measure":15,"description":11,"timeFrame":16},"Number of participants with treatment-emergent adverse events (TEAEs)","Up to Day 390",{"measure":18,"description":11,"timeFrame":16},"Percentage of participants with TEAEs",{"measure":20,"description":11,"timeFrame":16},"Number of participants with treatment-emergent serious adverse events (SAEs)",{"measure":22,"description":11,"timeFrame":16},"Percentage of participants with treatment-emergent SAEs",{"measure":24,"description":25,"timeFrame":26},"Number of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead electrocardiogram (ECG)","Clinical safety laboratory tests will include hematology, biochemistry and coagulation.","From Baseline to Day 390",{"measure":28,"description":25,"timeFrame":26},"Percentage of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead ECG",{"measure":30,"description":11,"timeFrame":31},"Change from baseline in transferrin saturation (TSAT) (measured at trough)","From Baseline to Day 360",{"measure":33,"description":11,"timeFrame":31},"Number of participants with TSAT less than or equal to (\u003C=) 45% (measured at trough)",{"measure":35,"description":11,"timeFrame":31},"Percentage of participants with TSAT \u003C= 45% (measured at trough)",{"measure":37,"description":11,"timeFrame":38},"Number of participants with 25% reduction in MRI-based LIC","At Day 180 and 360",{"measure":40,"description":11,"timeFrame":41},"Number of participants with 50% reduction in MRI-based LIC","At Day 180 and Day 360",{"measure":43,"description":11,"timeFrame":44},"Number of participants with TSAT ≤ 45% or MRI-based LIC \u003C 5 milligrams per gram (mg\u002Fg)","At Day 360",{"measure":46,"description":11,"timeFrame":44},"Number of participants with TSAT ≤ 45% or MRI-based LIC \u003C 2 mg\u002Fg",{"measure":48,"description":49,"timeFrame":31},"Change from baseline in joint pain score in a visual analog scale (VAS)","The VAS is a single-item questionnaire. Participants will be asked to record their joint pain at its worst over the previous week, from 0 (No pain) to 10 (Worst possible pain).",{"measure":51,"description":52,"timeFrame":31},"Change from baseline in modified fatigue impact scale (MFIS) total score","Participants will be asked to read a list of 21 statements and assess how often fatigue has affected them in terms of physical, cognitive, and psychosocial functioning, over the previous 4 weeks, using a 5-point scale from 0 (Never) to 4 (Almost always). The total score is obtained by summing the scores of all the 21 items. Higher scores indicate a greater impact of fatigue on a participant's activities.",{"measure":54,"description":55,"timeFrame":56},"Change from baseline in health-related quality of life: EuroQoL 5-dimension 5-level instrument (EQ-5D-5L)","The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health for clinical and economic appraisal. Participants will complete the questionnaire based on their health on that day. The EQ-5D-5L descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain \u002F discomfort, and anxiety \u002F depression. Participants will rate each dimension based on 5 levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. A higher score indicates a more severe outcome than a lower score.","From Baseline to Days 180, 360, and 390",{"measure":58,"description":49,"timeFrame":59},"Change from baseline in health-related quality of life: VAS (Arthralgia)","From Baseline to Day 180, 360, and 390",{"measure":61,"description":62,"timeFrame":59},"Change from baseline in health-related quality of life: Patient global impression of change in clinical status","The PGI - Change (PGI-C) instrument is a self-reported measure that reflects belief about the efficacy of treatment. Participants will be asked to rate the change in their overall symptoms since they started taking investigational product (IP) on a 5-point scale, ranging from 1 (Much improved) to 5 (Much worse). A lower score reflects an improvement in clinical status.",{"measure":64,"description":65,"timeFrame":59},"Change from baseline in health-related quality of life: Patient global impression of severity","The PGI - Severity (PGI-S) instrument is a self-reported questionnaire and consists of 1 item that measures disease severity. Participants will be asked to rate the severity of their overall symptoms over the previous week on a 5-point scale from 1 (None) to 5 (Very severe). A higher score reflects a more severe outcome than a lower score.",{"measure":67,"description":68,"timeFrame":59},"Change from baseline in health-related quality of life: MFIS physical, cognitive, and psychosocial subscales","Participants will be asked to read a list of 21 statements and assess how often fatigue has affected them in terms of physical, cognitive, and psychosocial functioning, over the previous 4 weeks, using a 5-point scale from 0 (Never) to 4 (Almost always).\n\nItems on the MFIS will be aggregated into 3 subscales (Physical, Cognitive, or Psychosocial). Higher scores indicate a greater impact of fatigue on a participant's activities.",{"measure":70,"description":11,"timeFrame":71},"Vamifeport plasma concentrations after a single dose","At Day 1",{"measure":73,"description":11,"timeFrame":74},"Vamifeport plasma concentrations at steady state","At Days 15, 180, and 360",{"measure":76,"description":11,"timeFrame":31},"Change from baseline in total serum iron (measured at trough)",{"measure":78,"description":11,"timeFrame":31},"Change from baseline in serum ferritin (measured at trough)",{"measure":80,"description":81,"timeFrame":16},"Frequency of rescue therapy use","For assessment of this outcome measure, data will be collected retrospectively from 1 year before baseline as well as during the study (up to Day 390).",{"measure":83,"description":81,"timeFrame":16},"Duration of rescue therapy use",{"measure":85,"description":11,"timeFrame":86},"Time to first use of rescue therapy","Up to Day 360",{"allocation":88,"interventionModel":89,"interventionModelDescription":90,"primaryPurpose":91,"observationalModel":11,"timePerspective":11,"maskingInfo":92},"RANDOMIZED","PARALLEL","This is multicenter, randomized, placebo-controlled double-blind, parallel-group study.","TREATMENT",{"masking":93,"maskingDescription":11,"whoMasked":94},"QUADRUPLE",[95,96,97,98],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[100,106,110],{"label":101,"type":102,"description":103,"interventionNames":104},"Vamifeport Low Dose","EXPERIMENTAL","Participants will receive a low dose of vamifeport orally, twice daily (BID) up to Day 360.",[105],"Drug: Vamifeport",{"label":107,"type":102,"description":108,"interventionNames":109},"Vamifeport High Dose","Participants will receive a high dose of vamifeport orally, BID up to Day 360.",[105],{"label":111,"type":112,"description":113,"interventionNames":114},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo matching vamifeport low and high doses orally, BID up to Day 360.",[115],"Drug: Placebo",[117,122],{"type":118,"name":119,"description":120,"armGroupLabels":121,"otherNames":11},"DRUG","Vamifeport","Vamifeport capsule administered orally.",[107,101],{"type":118,"name":111,"description":123,"armGroupLabels":124,"otherNames":11},"Placebo capsule matching IP administered orally.",[111],[126],{"name":127,"role":128,"phone":129,"phoneExt":11,"email":130},"Trial Registration Coordinator","CONTACT","+16108784697","clinicaltrials@cslbehring.com",[132,146,156,162,173,183,193,203,212,221,231,241,251,261,270,280,290,300,310,320,328,336,344,353,363,371,379,389,397,405,413,421,431,439,447,456,464,472,482,490,498,508,516,524,532,540,548,556,564,572,580,588,598,606,614,622,632,640,645,655,663,671,679,687,695,705,713,724,730,740,748,756,766,774,782,790,795,805,813,816,824,832,840,848,858,866,874,886,894,902,910,918,923,931,939,947,955,963],{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":11},"Banner MD Anderson","NOT_YET_RECRUITING","Gilbert","Arizona","85234-2165","United States","US",{"type":141,"coordinates":142},"Point",[143,144],-111.78903,33.35283,{"lat":144,"lon":143},{"facility":147,"status":134,"city":148,"state":149,"zip":150,"country":138,"countryCode":139,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Infinity Clinical Trials","San Diego","California","92108",{"type":141,"coordinates":152},[153,154],-117.16472,32.71571,{"lat":154,"lon":153},{"facility":157,"status":134,"city":148,"state":149,"zip":158,"country":138,"countryCode":139,"cosmosGeoPoint":159,"geoPoint":161,"contacts":11},"Medical Oncology Associates of San Diego","92123",{"type":141,"coordinates":160},[153,154],{"lat":154,"lon":153},{"facility":163,"status":164,"city":165,"state":166,"zip":167,"country":138,"countryCode":139,"cosmosGeoPoint":168,"geoPoint":172,"contacts":11},"Green Leaf Clinical Trials","RECRUITING","Jacksonville","Florida","32258",{"type":141,"coordinates":169},[170,171],-81.65565,30.33218,{"lat":171,"lon":170},{"facility":174,"status":164,"city":175,"state":176,"zip":177,"country":138,"countryCode":139,"cosmosGeoPoint":178,"geoPoint":182,"contacts":11},"Indiana University Health University Hospital","Indianapolis","Indiana","46202-5149",{"type":141,"coordinates":179},[180,181],-86.15804,39.76838,{"lat":181,"lon":180},{"facility":184,"status":134,"city":185,"state":186,"zip":187,"country":138,"countryCode":139,"cosmosGeoPoint":188,"geoPoint":192,"contacts":11},"Ochsner Medical Complex - High Grove","Baton Rouge","Louisiana","70836",{"type":141,"coordinates":189},[190,191],-91.18747,30.44332,{"lat":191,"lon":190},{"facility":194,"status":134,"city":195,"state":196,"zip":197,"country":138,"countryCode":139,"cosmosGeoPoint":198,"geoPoint":202,"contacts":11},"Johns Hopkins University School of Medicine","Baltimore","Maryland","21205",{"type":141,"coordinates":199},[200,201],-76.61219,39.29038,{"lat":201,"lon":200},{"facility":204,"status":164,"city":205,"state":196,"zip":206,"country":138,"countryCode":139,"cosmosGeoPoint":207,"geoPoint":211,"contacts":11},"American Oncology Partners, PA dba The Center for Cancer and Blood Disorders","Bethesda","20817",{"type":141,"coordinates":208},[209,210],-77.10026,38.98067,{"lat":210,"lon":209},{"facility":213,"status":134,"city":214,"state":196,"zip":215,"country":138,"countryCode":139,"cosmosGeoPoint":216,"geoPoint":220,"contacts":11},"James M. Stockman Cancer Institute","Frederick","21702-4337",{"type":141,"coordinates":217},[218,219],-77.41054,39.41427,{"lat":219,"lon":218},{"facility":222,"status":134,"city":223,"state":224,"zip":225,"country":138,"countryCode":139,"cosmosGeoPoint":226,"geoPoint":230,"contacts":11},"University of Michigan Health System (UMHS)","Ann Arbor","Michigan","48109",{"type":141,"coordinates":227},[228,229],-83.74088,42.27756,{"lat":229,"lon":228},{"facility":232,"status":164,"city":233,"state":234,"zip":235,"country":138,"countryCode":139,"cosmosGeoPoint":236,"geoPoint":240,"contacts":11},"Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology","Duluth","Minnesota","55805",{"type":141,"coordinates":237},[238,239],-92.10658,46.78327,{"lat":239,"lon":238},{"facility":242,"status":134,"city":243,"state":244,"zip":245,"country":138,"countryCode":139,"cosmosGeoPoint":246,"geoPoint":250,"contacts":11},"Hunterdon Hematology Oncology, LLC","Flemington","New Jersey","08822",{"type":141,"coordinates":247},[248,249],-74.85933,40.51233,{"lat":249,"lon":248},{"facility":252,"status":134,"city":253,"state":254,"zip":255,"country":138,"countryCode":139,"cosmosGeoPoint":256,"geoPoint":260,"contacts":11},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27517-7518",{"type":141,"coordinates":257},[258,259],-79.05584,35.9132,{"lat":259,"lon":258},{"facility":262,"status":134,"city":263,"state":254,"zip":264,"country":138,"countryCode":139,"cosmosGeoPoint":265,"geoPoint":269,"contacts":11},"Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir","Durham","27710-4000",{"type":141,"coordinates":266},[267,268],-78.89862,35.99403,{"lat":268,"lon":267},{"facility":271,"status":164,"city":272,"state":273,"zip":274,"country":138,"countryCode":139,"cosmosGeoPoint":275,"geoPoint":279,"contacts":11},"Hightower Clinical - Oklahoma Cancer Center","Oklahoma City","Oklahoma","73174",{"type":141,"coordinates":276},[277,278],-97.51643,35.46756,{"lat":278,"lon":277},{"facility":281,"status":134,"city":282,"state":283,"zip":284,"country":138,"countryCode":139,"cosmosGeoPoint":285,"geoPoint":289,"contacts":11},"Cancer Care Associates of York","York","Pennsylvania","17403-5060",{"type":141,"coordinates":286},[287,288],-76.72774,39.9626,{"lat":288,"lon":287},{"facility":291,"status":134,"city":292,"state":293,"zip":294,"country":138,"countryCode":139,"cosmosGeoPoint":295,"geoPoint":299,"contacts":11},"Intermountain Medical Center","Murray","Utah","84107",{"type":141,"coordinates":296},[297,298],-111.88799,40.66689,{"lat":298,"lon":297},{"facility":301,"status":164,"city":302,"state":303,"zip":304,"country":138,"countryCode":139,"cosmosGeoPoint":305,"geoPoint":309,"contacts":11},"Washington State Univ Elson S. Floyd College of Medicine","Spokane","Washington","99202-2131",{"type":141,"coordinates":306},[307,308],-117.42908,47.65966,{"lat":308,"lon":307},{"facility":311,"status":134,"city":312,"state":11,"zip":11,"country":313,"countryCode":314,"cosmosGeoPoint":315,"geoPoint":319,"contacts":11},"Royal Brisbane and Women's Hospital","Brisbane","Australia","AU",{"type":141,"coordinates":316},[317,318],153.02809,-27.46794,{"lat":318,"lon":317},{"facility":321,"status":134,"city":322,"state":11,"zip":11,"country":313,"countryCode":314,"cosmosGeoPoint":323,"geoPoint":327,"contacts":11},"Gallipoli Medical Research","Chandler",{"type":141,"coordinates":324},[325,326],153.14907,-27.51398,{"lat":326,"lon":325},{"facility":329,"status":134,"city":330,"state":11,"zip":11,"country":313,"countryCode":314,"cosmosGeoPoint":331,"geoPoint":335,"contacts":11},"Monash Medical Centre","Clayton",{"type":141,"coordinates":332},[333,334],145.11667,-37.91667,{"lat":334,"lon":333},{"facility":337,"status":134,"city":338,"state":11,"zip":11,"country":313,"countryCode":314,"cosmosGeoPoint":339,"geoPoint":343,"contacts":11},"Trials West","Perth",{"type":141,"coordinates":340},[341,342],115.8614,-31.95224,{"lat":342,"lon":341},{"facility":345,"status":134,"city":346,"state":11,"zip":347,"country":313,"countryCode":314,"cosmosGeoPoint":348,"geoPoint":352,"contacts":11},"Westmead Hospital for Medical Research","Westmead","2145",{"type":141,"coordinates":349},[350,351],150.98768,-33.80383,{"lat":351,"lon":350},{"facility":354,"status":134,"city":355,"state":11,"zip":11,"country":356,"countryCode":357,"cosmosGeoPoint":358,"geoPoint":362,"contacts":11},"Medical University of Innsbruck","Innsbruck","Austria","AT",{"type":141,"coordinates":359},[360,361],11.39454,47.26266,{"lat":361,"lon":360},{"facility":364,"status":134,"city":365,"state":11,"zip":11,"country":356,"countryCode":357,"cosmosGeoPoint":366,"geoPoint":370,"contacts":11},"Ordensklinikum Linz - Barmherzige Schwestern","Linz",{"type":141,"coordinates":367},[368,369],14.28611,48.30639,{"lat":369,"lon":368},{"facility":372,"status":134,"city":373,"state":11,"zip":11,"country":356,"countryCode":357,"cosmosGeoPoint":374,"geoPoint":378,"contacts":11},"Medical University Vienna","Vienna",{"type":141,"coordinates":375},[376,377],16.37208,48.20849,{"lat":377,"lon":376},{"facility":380,"status":134,"city":381,"state":11,"zip":11,"country":382,"countryCode":383,"cosmosGeoPoint":384,"geoPoint":388,"contacts":11},"Universitair Ziekenhuis Antwerpen (UZA)","Edegem","Belgium","BE",{"type":141,"coordinates":385},[386,387],4.44504,51.15662,{"lat":387,"lon":386},{"facility":390,"status":134,"city":391,"state":11,"zip":11,"country":382,"countryCode":383,"cosmosGeoPoint":392,"geoPoint":396,"contacts":11},"Ghent University Hospital","Ghent",{"type":141,"coordinates":393},[394,395],3.71667,51.05,{"lat":395,"lon":394},{"facility":398,"status":134,"city":399,"state":11,"zip":11,"country":382,"countryCode":383,"cosmosGeoPoint":400,"geoPoint":404,"contacts":11},"UZ Brussel","Jette",{"type":141,"coordinates":401},[402,403],4.33419,50.87309,{"lat":403,"lon":402},{"facility":406,"status":134,"city":407,"state":11,"zip":11,"country":382,"countryCode":383,"cosmosGeoPoint":408,"geoPoint":412,"contacts":11},"Centre Hospitalier Universitaire de Liège (CHU de Liège)","Liège",{"type":141,"coordinates":409},[410,411],5.56749,50.63373,{"lat":411,"lon":410},{"facility":414,"status":134,"city":415,"state":11,"zip":11,"country":382,"countryCode":383,"cosmosGeoPoint":416,"geoPoint":420,"contacts":11},"CHU UCL Namur - 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