[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ph1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ph1":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100637819","phase-2-study-of-yolt-203-in-children-and-adults-with-primary-hyperoxaluria-type-1-ph1-100637819",false,"NCT07587021","Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)","A Randomized, Double-blind, Placebo-controlled Study Followed by a Treatment Extension to Evaluate the Efficacy and Safety of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1","Inclusion Criteria\n\n* You are 6 years old or older.\n* You have been diagnosed with PH1 (primary hyperoxaluria type 1) through genetic testing.\n* Urine tests show that your oxalate levels are not within certain limits (based on at least two 24-hour urine collections).\n* If you take vitamin B6, your dose has been stable for at least 3 months, and you are willing to keep it the same during the study.\n* You (and\u002For your parent or legal guardian, if you are under 18) understand the study and agree to follow all study requirements, including signing a consent form.\n\nExclusion Criteria\n\n* You have signs that oxalate has affected parts of your body outside the kidneys.\n* Your liver blood tests are not within certain limits.\n* You have certain abnormal blood clotting results (unless controlled with medication like warfarin).\n* You have HIV, or active or chronic hepatitis C.\n* You are pregnant, planning to become pregnant, or breastfeeding.\n* You are not willing to use birth control during the study and for 6 months after (if applicable).\n* You are unable to limit alcohol intake to no more than about 2 drinks per day.\n* You have had alcohol or drug abuse in the past year.\n* You are unable to follow standard treatments for PH1 (such as drinking plenty of fluids, taking prescribed medications like potassium citrate, or following dietary advice).","ALL","6 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1.\n\nAfter the initial randomized, 6-month double-blind, placebo-controlled period, participants who were initially assigned to placebo will receive a single-dose of YOLT-203 treatment whereas participants in the YOLT-203 group will receive a single-dose of placebo infusion.",[26,27],"Primary Hyperoxaluria Type 1","PH1",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"ph1","primary hyperoxaluria Type 1","yoltech","yolt203","primary hyperoxaluria","recurrent kidney stones","rare kidney stones","YOLT-203","genetic kidney stones","gene editing","gene therapy","AGXT gene","CRISPR-Cas9","Alanine Glyoxylate Aminotransferase Gene","NOT_YET_RECRUITING","2026-05-07",{"date":46,"type":47},"2026-05-14","ACTUAL",{"date":49,"type":20},"2026-06",{"date":51,"type":20},"2028-02",{"name":53,"class":54},"YolTech Therapeutics Co., Ltd","INDUSTRY"]