[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"factor-v-leiden\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:factor-v-leiden":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100639633","engagement-study-for-participants-with-factor-v-leiden-and-prothrombin-g20210a-mutations-100639633",false,"NCT07584265","Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations","Engagement Study to Establish a Clinical Baseline for Adult Participants With Factor V Leiden or Prothrombin G20210A Mutation and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation.","Inclusion Criteria:\n\n1. Male or female participants aged ≥ 18 years at the date of signing the Participant Information Sheet\u002FInformed Consent Form (PIS\u002FICF).\n2. Ability to provide written, personally signed, and dated informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines E6 (R3) (2025) and applicable regulations, before any study-specific procedures are performed.\n3. Confirmed or suspected diagnosis of FVL or Prothrombin G20210A mutation via targeted genetic testing.\n\nExclusion Criteria:\n\n1. Unwilling or unable to comply with the protocol-defined study assessments.\n2. Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","This study will enrol individuals who have, or may have, Factor V Leiden or Prothrombin G20210A mutations, which are genetic changes linked to an increased risk of blood clots. Targeted genetic testing will be carried out, where appropriate, to confirm whether participants have one of these genetic variants. Those with a confirmed result will attend a site visit for basic health checks, including blood pressure measurements, ECG, and blood tests, to establish a baseline of their general health and help identify suitability for future related clinical trials.\n\nThe study also provides participants with the opportunity to learn more about clinical research and become familiar with the clinical trial unit and team. Participation lasts approximately 10 weeks and includes 1-2 site visits and a follow-up telephone call.",[24,25],"Factor V Leiden","Prothrombin G20210A","RECRUITING","2026-05-26",{"date":29,"type":30},"2026-05-29","ACTUAL",{"date":32,"type":30},"2026-04-21",{"date":34,"type":20},"2027-01-31",{"name":36,"class":37},"Richmond Research Institute","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":38},"100626035","phase-1-a-single-ascending-dose-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-city-fxi-in-healthy-adults-and-adults-with-fv-leiden-or-prothrombin-g20210a-mutation-100626035","NCT07430397","A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults and Adults With FV Leiden or Prothrombin G20210A Mutation","A Phase 1, Randomised, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-FXI, a FXI Targeting siRNA, Administered Subcutaneously in Healthy Adults and Adults With Factor V Leiden or Prothrombin G20210A Mutation","Inclusion Criteria:\n\n* Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (Part A only)\n* Male and female participants aged 18 to 60 (Part B only)\n* Body Mass Index (BMI) between 18 and 25 kg\u002Fm2 (inclusive) and a minimum weight of 50 kg\n* Ability and willingness to comply fully with all study procedures and lifestyle considerations\n* Confirmed diagnosis of FVL or prothrombin G20210A mutation via genetic testing (Part B only)\n* Women of childbearing potential (WOCBP) must agree to use acceptable highly effective contraceptive methods (Part B only)\n\nExclusion Criteria:\n\n* Any clinically significant systemic disease or disorder, including but not limited to cardiovascular, hepatic, or oncological conditions\n* History or evidence of any bleeding disorders\n* History of clinically significant spontaneous bleeding\n* Prior treatment with an investigational agent\n* Confirmed diagnosis of homozygous mutations, or combined thrombophilic defects of (Part B only)",true,"60 Years",{"count":49,"type":20},128,"INTERVENTIONAL",[52],"PHASE1","This is a first-in-human (FIH), single-center, randomised, double-blind, placebo-controlled, single ascending dose (SAD) study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation.",[24,25],[56,57],"Factor XI","siRNA","2026-02-18",{"date":60,"type":30},"2026-02-24",{"date":62,"type":30},"2026-01-22",{"date":64,"type":20},"2027-10",{"name":66,"class":37},"City Therapeutics"]