[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"klippel-trenaunay-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:klippel-trenaunay-syndrome":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,81,106],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100576793","phase-2-a-phase-2-study-of-mutant-selective-pi3k-inhibitor-rly-2608-in-adults-and-children-with-pik3ca-related-overgrowth-spectrum-and-malformations-driven-by-pik3ca-mutation-the-reinspire-study-100576793",false,"NCT06789913","A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)","A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation","Key Inclusion Criteria:\n\n* The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.\n* One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and\u002For cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.\n* Lansky (\\\u003C16 yo) or Karnofsky (≥16 yo) performance status of ≥50.\n* Agree to provide archived lesional fluid and\u002For tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to RLY-2608.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* Clinically significant, uncontrolled cardiovascular disease\n* Received disease-directed therapy prior to the first dose of study drug:\n\n  1. Systemic therapy or antibody within 5 half-lives of the therapy.\n  2. Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.","ALL","2 Years",{"count":19,"type":20},277,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.",[26,27,28,29,30,31,32,33],"PIK3CA-Related Overgrowth Spectrum (PROS)","Lymphatic Malformations","Vascular Malformations","PIK3CA Mutation","CLOVES Syndrome","Klippel Trenaunay Syndrome","Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)","Vascular Anomalies","RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-12","ACTUAL",{"date":40,"type":38},"2025-06-13",{"date":42,"type":20},"2031-10",{"name":44,"class":45},"Relay Therapeutics, Inc.","INDUSTRY",34,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":68,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100239778","lymphatic-anomalies-registry-for-the-assessment-of-outcome-data-100239778","NCT02399527","Lymphatic Anomalies Registry for the Assessment of Outcome Data","Inclusion Criteria:\n\n* Clinical diagnosis of complex vascular tumor, malformation or overgrowth syndrome with significant lymphatic component",{"count":54,"type":20},1000,"15 Years","OBSERVATIONAL","Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the understanding of the natural history, long-term outcomes, risk factors for morbidity and mortality, and the relative benefit of medical therapies and procedures is limited.The goal of this project is to better understand these diseases and improve the care of theses rare patients. To do this, the investigators are conducting an observational study of patients with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective data on mortality, morbidity, treatments, and functionality as well as quality of life.",[59,60,61,30,62,63,64,65,66,67],"Lymphatic Malformation","Generalized Lymphatic Anomaly (GLA)","Central Conducting Lymphatic Anomaly","Gorham-Stout Disease (\"Disappearing Bone Disease\")","Blue Rubber Bleb Nevus Syndrome","Kaposiform Lymphangiomatosis","Kaposiform Hemangioendothelioma\u002FTufted Angioma","Klippel-Trenaunay Syndrome","Lymphangiomatosis",[33,69,59],"Lymphatic Anomalies","2026-04-21",{"date":72,"type":38},"2026-04-24",{"date":74,"type":38},"2013-06",{"date":76,"type":20},"2035-06",{"name":78,"class":79},"Boston Children's Hospital","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100614854","phase-3-a-study-to-investigate-efficacy-and-safety-of-kp-001-compared-with-placebo-in-patients-aged-2-years-with-common-vm-common-lm-or-ktscloves-syndrome-100614854","NCT07285005","A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS\u002FCLOVES Syndrome","A Phase 3, Randomized, Parallel, Multicenter, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of KP 001 in Patients Aged ≥2 Years With Common Venous Malformations, Common Lymphatic Malformations, or KTS\u002FCLOVES Syndrome","S-KY","Inclusion Criteria:\n\n1. Patients aged 2 years or older at the time of consent or assent.\n2. Patients diagnosed with ISSVA classification of common VM, common (cystic) LM (including mixed type consisting mainly of either VM or LM), or KTS\u002FCLOVES syndrome.\n3. Patients who cannot be cured by resection, who are difficult to resect based on the assessment of the Investigator, or who are considered refractory to available treatment by the Investigator, or who have a contraindication to available treatment.\n4. Patients with at least one target lesion at least 4 cm in the longest diameter.\n5. Patients with at least one MRI-volumetric target lesion at screening that is determined to be evaluable by the central imaging evaluator.\n6. Patients with symptomatic disease, defined as:\n\n   ・ For patients ≥8 years old: Pain NRS of ≥1 and ≤8 score at the screening visit will be eligible only if their daily pain NRS recorded via ePRO from screening to Day 1 (Week 0) does not show a maximum absolute change of ≥6 points. If patients are taking analgesic medication, there must be no change in the type or dosage of analgesic during the screening period. If patients do not have qualifiable pain, then Fatigue or Bleeding\u002FOozing NRS of ≥1 and ≤8 score at the screening visit is required. Patients with ≥6 points absolute change in pain NRS are eligible if at least one of either Fatigue OR Bleeding\u002FOozing NRS is ≥1 and ≤8.\n   * For patients ≥3 years old to \\\u003C8 years old: Wong-Baker FACES pain rating scale equal to or greater than 2 points at screening visit. Patients who are ≥3 years old to \\\u003C8 years old without qualifiable pain will be recruited providing they have symptomatic disease as judged in the opinion of the Investigator (ie, any visible lesion or lesion affecting activities of daily living), and as far as they meet other inclusion criteria.\n   * For patients 2 years old: Symptomatic disease as judged in the opinion of the Investigator (ie, any visible lesion or lesion affecting activities of daily living), and patients will be recruited as far as they meet other inclusion criteria.\n7. Patients whose pain from vascular malformations has been stable for at least 30 days prior to screening and, if taking analgesic medication, does not require a change in the type of analgesic medication or its dosage during the screening period.\n8. Patients who agree that they or their partner (if either of them is of childbearing potential) will use appropriate contraception (eg, condom and spermicide combination, low-dose pills or other appropriate contraceptive methods, sterilization, intrauterine device) from the time of consent until 90 days after the last dose of study intervention.\n9. Patients or their LAR who are able to give age-appropriate informed consent at the time of screening.\n10. Patients who are judged by the Investigator to be able to comply with the instructions of the Investigator and the study coordinator regarding the matters specified in the protocol, such as the use of study intervention and concomitant use of prohibited drugs.\n\nExclusion Criteria:\n\n1. Patients with the following diseases: Simple telangiectatic malformation, lymphangiomatosis, lymphangiectatic malformation associated with Gorham's disease, lymphangiectasia, familial cutaneous mucocutaneous venous malformation, blue rubber ball-like nevus syndrome, M-CM\u002FMCAP, CLAPO syndrome, Proteus syndrome, Parkes Weber syndrome, Sturge-Weber syndrome, Mafucci syndrome, Osler's disease, Cowden's disease, or Adams-Oliver syndrome.\n2. Patients with uncontrolled diabetes mellitus (HbA1c ≥ 7.0%) or diseases with abnormal glucose metabolism (glycogenic diseases, galactosemia, primary lactose intolerance, etc).\n3. Patients with ischemic heart disease, arrhythmia, or heart failure (NYHA III or IV).\n4. Patients with gastrointestinal disorders that affect drug absorption, as determined by the Investigator.\n5. Patients with concomitant or pre-existing serious drug hypersensitivity to PI3Kα inhibitors.\n6. Patients with allergy history of grade ≥ 3 and\u002For history of grade ≥ 3 allergic reactions to drug.\n7. Patients with known hypersensitivity to quinine.\n8. Patients with concomitant or pre-existing alcohol or drug abuse.\n9. Patients with ANC of \\\u003C1.5×10\\^9\u002FL.\n10. Patients with acute or chronic kidney disease and\u002For dialysis dependence. Patients with screening eGFR \\\u003C30 mL\u002Fmin\u002F1.73m\\^2 using the beside Schwartz equation for patients aged \\\u003C18 years of age or CKD-EPI formula for \\>18 years of age will also be excluded.\n11. Patients who are judged by the Investigator to have hepatic impairment.\n12. Patients with total bilirubin ≥1.5×ULN for age (unless there is a history of Gilbert Syndrome), ALT ≥2×ULN for age, or AST ≥2×ULN for age will be excluded.\n13. Patients with target lesion infection that require treatment within 28 days prior to screening.\n14. Patients who have undergone invasive treatment, including sclerotherapy or laser therapy, for the target lesion within 84 days prior to screening.\n15. Patients who have used other PI3Kα inhibitors or sirolimus within 84 days prior to screening.\n16. Patients who have participated in other clinical studies within 90 days prior to the date of consent.\n17. Patients who have participated in a clinical study of KP-001 for any period and have received an investigational drug in the past year.\n18. Patients wearing orthodontic appliances, cochlear implants, etc, that may affect MRI, or patients in whom MRI is not feasible or, for example, patients who may have a contraindication to sedation and would require sedation in order to have MRI completed.\n19. Patients who are unable to take oral medications.\n20. Pregnant women, lactating female patients, female patients who may be pregnant, female patients who wish to become pregnant during the study period and up to 90 days after the last dose of study intervention, or male patients who have partners who wish to become pregnant.\n21. Patients with any other illness or medical condition who are judged by the Investigator to be inappropriate as patients for this study.\n22. Patients who have received or plan to receive live vaccines during the study period.",{"count":90,"type":20},150,[92],"PHASE3","This is a phase 3, double-blind, randomized, placebo-controlled, parallel group, adaptive, multicenter study planned to be conducted at multiple sites in North America, Canada, Taiwan and South Korea.\n\nThe purpose of this study is to measure the efficacy and safety of KP-001 compared with placebo in patients aged ≥2 years with common VM, common LM, or KTS\u002FCLOVES syndrome.\n\nAn independent data monitoring committee (DMC) will be established to determine whether to discontinue or continue the study. It will also determine the redesign of the number of cases based on the result of the interim analysis.\n\nThe study will comprise the following:\n\n* Screening Period: Up to 42 days prior to the first dose of study intervention.\n* Treatment Period 1: This is a double-blind period in which KP-001 100 mg (or lower dose depending on their body weight) or placebo will be administered to patients once daily after breakfast until Week 24.\n* Treatment Period 2: After 24 weeks of double blind treatment, all patients will switch to the KP-001 open label extension and treated up to Week 52.\n* Follow-up Visit: This visit will occur 30 days after the last dose of study intervention, and assessments will be performed per the SoA.\n* Discontinuation Visit: Patients who discontinue study intervention will be requested to continue participating in the study and assessments will be performed per the SoA. If the patients request to withdraw from the study, all tests and evaluations when possible will be performed at Discontinuation visit.",[95,27,66,30],"Venous Malformations","NOT_YET_RECRUITING","2025-12-18",{"date":99,"type":38},"2025-12-19",{"date":101,"type":20},"2026-02-26",{"date":103,"type":20},"2028-02",{"name":105,"class":45},"Kaken Pharmaceutical",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100285864","identification-of-biomarkers-for-patients-with-vascular-anomalies-100285864","NCT03001180","Identification of Biomarkers for Patients with Vascular Anomalies","Inclusion Criteria:\n\n* Any patient having labs drawn as standard of care will have blood drawn for the study if consented\u002F assented.\n* All patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank.\n\nExclusion Criteria:\n\n* N\u002FA","1 Day",{"count":54,"type":20},"The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. The study will also use blood (serum and plasma) and tissue collected and stored in a tissue bank maintained by the Department of Hematology\u002FOncology.",[116,117,118,64,119,31,120],"Vascular Anomaly","Generalized Lymphatic Anomaly","Kaposiform Hemangioendothelioma","Gorham-Stout Disease","Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi",[117,116,118,64,122,123,124,125,126,127],"Vascular Endothelial Growth Factor","Biomarkers","GLA","KLA","KHE","GSD","2024-11-05",{"date":130,"type":38},"2024-11-06",{"date":132,"type":4},"2015-04",{"date":134,"type":20},"2050-12",{"name":136,"class":79},"Children's Hospital Medical Center, Cincinnati",2]