[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536110":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":30,"responsibleParty":32,"collaborators":36,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":30,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":30,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":30},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants with Biliary Atresia","EXPERIMENTAL","* Administering applesauce alone\n* Administering applesauce plus NAC (for infants who tolerate applesauce alone)",[13],"Drug: N-Acetylcysteine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","N-Acetylcysteine","This is a phase 1 study of tolerance of a novel delivery method of oral NAC medication in infants with biliary atresia. The study consists of two parts:\n\n* Administering applesauce alone (lead-in): In study days 1-2, infants will receive one infant spoon (approximately ½ teaspoon) of plain applesauce by mouth twice a day. If the infant tolerates 3-4 of 4 total doses without emesis, the infant will progress to the final two days of the study.\n* Administering applesauce plus NAC (for infants who tolerate applesauce in study days 1-2): In study days 3-4, infants will receive an individualized dose of powdered oral NAC mixed into one infant spoon of applesauce by mouth twice a day for a maximum of four doses of NAC medication. 4 doses will be trialed: 150 mg\u002Fkg\u002Fday, 240 mg\u002Fkg\u002Fday, 330 mg\u002Fkg\u002Fday, and 420 mg\u002Fkg\u002Fday using BOIN study design for dose escalation.",[9],[21],"NAC",[23],{"name":24,"affiliation":5,"role":25},"Sanjiv Harpavat, M.D., PH.D.","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","832-824-3896",null,"harpavat@bcm.edu",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Sanjiv Harpavat","Associate Professor",[37],{"name":5,"class":6},"100536110","phase-1-tolerability-of-enteral-nac-in-infants-100536110",false,"NCT06260566","Tolerability of Enteral NAC in Infants","A Phase 1 Trial of Tolerability of Enteral N-Acetylcysteine in Infants","Inclusion Criteria:\n\n* 122-273 days of life at time of enrollment\n* Confirmed diagnosis of biliary atresia based on intraoperative cholangiogram\n* Able to tolerate oral nutrition and medications and not on continuous tube feeds\n* Anticipated inpatient admission of at least 4 days\n* Legal guardian(s) consent to study enrollment after understanding the risks and investigational nature of the study\n\nExclusion Criteria:\n\n* Gestational age of \\\u003C32 weeks at birth\n* Inability or contraindication to taking oral nutrition\n* Neonatal intensive care unit admission\n* Short bowel, or other malabsorptive, syndrome\n* Decompensated liver disease (INR \\> 1.3 despite vitamin K administration)\n* Active respiratory infection\n* Severe concurrent illnesses that would interfere with the conduct and\u002For results of the study\n* Concurrent participation in another drug trial","ALL","122 Days","273 Days",{"count":49,"type":50},12,"ESTIMATED","INTERVENTIONAL",[53],"PHASE1","Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology.\n\nThis study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants.",[56],"Biliary Atresia",[56,17,58,59,60,61,62],"glutathione","bile flow","serum bilirubin","serum bile acids","cholestasis","NOT_YET_RECRUITING","2026-03-02",{"date":66,"type":67},"2026-03-04","ACTUAL",{"date":69,"type":50},"2026-10",{"date":71,"type":50},"2031-10",{"name":34,"class":6}]