[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622172":3},{"organization":4,"outcomesModule":7,"designInfo":7,"detailedDescription":8,"studyPopulation":7,"armGroups":7,"interventions":9,"overallOfficials":7,"centralContacts":17,"locations":7,"responsibleParty":26,"collaborators":7,"id":28,"slug":7,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":31,"acronym":7,"eligibilityCriteria":32,"healthyVolunteers":29,"sex":33,"minAge":7,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":34,"phases":7,"briefSummary":35,"conditions":36,"keywords":38,"overallStatus":41,"whyStopped":7,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":46,"locationsCount":7},{"fullName":5,"class":6},"IntraBio Inc","INDUSTRY",null,"This expanded access program provides access to investigational drug, levacetylleucine, for eligible patients with Ataxia-Telangiectasia that are not eligible for other clinical trials, and a medical doctor has decided there is potential benefit outweighing the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.",[10],{"type":11,"name":12,"description":13,"armGroupLabels":7,"otherNames":14},"DRUG","Levacetylleucine","1 gram levacetylleucine as granules in unit-dose packet. Investigational drug is administered as oral suspension, up to three times per day, based on body weight.",[15,16],"AQNEURSA","N-Acetyl-L-leucine",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"IntraBio Medical Affairs","CONTACT","1-833-306-9677","medinfo@intrabio.com",{"name":24,"role":20,"phone":7,"phoneExt":7,"email":25},"Megan Grosso","ibmedical@intrabio.com",{"type":27,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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.",[37],"Ataxia-Telangiectasia (A-T)",[39,40],"Ataxia-Telangiectasia","Louis Bar Syndrome","AVAILABLE","2026-02-20",{"date":44,"type":45},"2026-02-24","ACTUAL",{"name":5,"class":6}]