[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100258062":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":95,"collaborators":31,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":31,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":31,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":31,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with vascular malformations","EXPERIMENTAL","Patients with venous, lympathic or complex vascular malformations (KTS, PTEN, etc.) will receive sirolimus after completion of inclusion criteria",[13],"Drug: Sirolimus",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sirolimus","evaluate the efficacy and safety of sirolimus in these patients",[9],[21],"Rapamycine",[23],{"name":24,"affiliation":5,"role":25},"Laurence M Boon, MD, PhD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Laurence M. Boon, MD, PhD","CONTACT","+ 32-2-764 8020",null,"laurence.boon@uclouvain.be",[34,54,78],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Cliniques Universitaires Saint-Luc, Université Catholique de Louvain Bruxelles","RECRUITING","Brussels","Brussels Capital","1200","Belgium","BE",{"type":43,"coordinates":44},"Point",[45,46],4.34878,50.85045,{"lat":46,"lon":45},[49,50],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":51,"role":29,"phone":52,"phoneExt":31,"email":53},"Emmanuel Seront, MD, PhD","+ 32-2-764 1992","emmanuel.seront@uclouvain.be",{"facility":55,"status":36,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":31,"geoPoint":31,"contacts":61},"CHU Caen","Caen","Brittany Region","14000","France","FR",[62,65,68,71,73,75,77],{"name":63,"role":29,"phone":31,"phoneExt":31,"email":64},"Anne Dompmartin, MD, PhD","dompmartin-a@chu-caen.fr",{"name":66,"role":29,"phone":31,"phoneExt":31,"email":67},"Fabien Chaillot","chaillot-f@chu-caen.fr",{"name":69,"role":70,"phone":31,"phoneExt":31,"email":31},"Annouk Bisdorff Bresson, MD","SUB_INVESTIGATOR",{"name":72,"role":25,"phone":31,"phoneExt":31,"email":31},"Isabelle Quere, MD, PhD",{"name":74,"role":25,"phone":31,"phoneExt":31,"email":31},"Philippe Orcel, MD, PhD",{"name":76,"role":25,"phone":31,"phoneExt":31,"email":31},"Marie-Antoinette Sevestre, MD, PhD",{"name":63,"role":25,"phone":31,"phoneExt":31,"email":31},{"facility":79,"status":80,"city":81,"state":31,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Universitätsklinikum Freiburg","NOT_YET_RECRUITING","Freiburg im Breisgau","79106","Germany","DE",{"type":43,"coordinates":86},[87,88],7.85222,47.9959,{"lat":88,"lon":87},[91,94],{"name":92,"role":29,"phone":31,"phoneExt":31,"email":93},"Jochen Roessler, MD, PhD","jochen.roessler@uniklinik-freiburg.de",{"name":92,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":96,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100258062","phase-3-efficacy-and-safety-of-sirolimus-in-vascular-anomalies-that-are-refractory-to-standard-care-100258062",false,"NCT02638389","Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care","Phase III Multicentric Study Evaluating the Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care","Inclusion Criteria:\n\n* Patients with complex vascular anomalies that are refractory to standard care such as medical treatment, surgical resection and\u002For sclerotherapy\u002Fembolization (ineffective or accompanied by major complications)\n* Patients must have adequate medullary function: Hemoglobine\\> 10,0 g\u002Fdl, neutrophils \\>1500\u002Fmm³ and platelets \\> 100.000\u002Fmm³\n* Patients must have the following laboratory values:\n* Total serum bilirubin ≤ 1.5 x ULN (or totally bilirubin ≤ 3 x ULN with direct bilirubin ≤ 1.5 x ULN in patients with well documented Gilbert Syndrome)\n* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or \\\u003C 5.0 x ULN if hepatic metastases are present)\n* Serum creatinine 1.5 x ULN. If the serum creatinine is ≥ 1.5 x ULN, then a 24-hour Creatinine Clearance must be conducted and the result must be ≥ 60 mL\u002Fmin.\n* Karnofsky \\> 50\n* Patients have to be able to sign the informed consent\n* Women in age of procreation have to be informed that contraceptive methods are mandatory during the study time\n\nExclusion Criteria:\n\n* Any of the following concurrent severe and\u002For uncontrolled medical conditions, which could compromise participation in the study or interfere with the study results:\n* Impaired cardiac function or clinically significant cardiac diseases, including unstable angina pectoris, ventricular arrhythmia, valvular disease with documented compromise in cardiac function, myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function, history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy, family history of congenital long or short QT, or known history of QT\u002FQTc prolongation of Torsades de Pointes (TdP)\n* Impairment of Gastro-Intestinal (GI) function or GI disease that may significantly alter the absorption of sirolimus (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea ≥ Grade 2, malabsorption syndrome, or small bowel resection)\n* Known hypersensitivity to drugs or metabolites from similar classes as study treatment.\n* Patient has other concurrent severe and \u002For uncontrolled medical condition that would,in the investigator's judgment, contraindicated participation in the clinical study (e.g. acute or chronic pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function with a spirometry ≤ 50% of the normal predicted value and\u002For O2 saturation ≤ 88% at rest, etc.)\n* Immunocompromised patients, including known seropositivity for HIV\n* Pregnant or lactating women\n* Prior treatment with PI3K and\u002For mTOR inhibitors","ALL","3 Months","70 Years",{"count":108,"type":109},250,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","The phosphatidylinositol 3-kinase (PI3Kinase)\u002FProtein Kinase B (AKT)\u002Fmammalian target of rapamycin (mTor) pathway plays a role on the development and the venous\u002Flymphatic vascular organisations.\n\nThe investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.",[115],"Vascular Malformations","2023-02-23",{"date":118,"type":119},"2023-02-24","ACTUAL",{"date":121,"type":119},"2016-01-25",{"date":123,"type":109},"2030-04-01",{"name":5,"class":6},3]