[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ataxia-telangiectasia-a-t\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ataxia-telangiectasia-a-t":19},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":16,"phases":4,"briefSummary":17,"conditions":18,"keywords":20,"overallStatus":23,"whyStopped":4,"lastUpdateSubmitDate":24,"lastUpdatePostDateStruct":25,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":28,"locationsCount":4},"100622172","expanded-access-program-eap-of-levacetylleucine-for-ataxia-telangiectasia-a-t-100622172",false,"NCT07380165","Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)","Inclusion Criteria:\n\n1. Patient has a genetically confirmed diagnosis of Ataxia-Telangiectasia, a rare and serious disease with no alternative approved treatments.\n2. Patient and\u002For their legal representative signed a written informed consent and, if applicable, written assent.\n3. Patient weighs ≥15 kg.\n4. If female and of reproductive potential, the treating physician verified the patient is not pregnant prior to enrollment and will use adequate contraceptive methods to avoid pregnancy during and up to 7 days after participating in the program.\n5. Patient resides in the United States at time of enrollment and throughout the duration of their participation in the EAP.\n\nExclusion Criteria:\n\n1. Patient is enrolled in or early withdrew participation from a clinical trial with levacetylleucine for A-T.\n2. Patient is pregnant, breastfeeding, or considering pregnancy.\n3. Patient has a physical, cognitive, psychiatric condition, or an active or suspected malignancy that, in the judgment of the treating physician, may pose a safety risk or interfere with the patient's ability to comply with the EAP procedures.\n4. Patient is receiving N-acetyl-DL-leucine or N-acetyl-D-leucine and is unwilling to stop use throughout the duration of their participation in the EAP.\n5. Patient is receiving another investigational drug for any reason.","ALL","EXPANDED_ACCESS","This expanded access program provides investigational levacetylleucine to patients with Ataxia-Telangiectasia who are not eligible for clinical trials and have no satisfactory alternative therapies.",[19],"Ataxia-Telangiectasia (A-T)",[21,22],"Ataxia-Telangiectasia","Louis Bar Syndrome","AVAILABLE","2026-02-20",{"date":26,"type":27},"2026-02-24","ACTUAL",{"name":29,"class":30},"IntraBio Inc","INDUSTRY"]