[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428681":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":73,"centralContacts":86,"locations":96,"responsibleParty":433,"collaborators":435,"id":438,"slug":439,"hasResults":440,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":440,"sex":446,"minAge":447,"maxAge":448,"enrollmentInfo":449,"targetDuration":33,"studyType":452,"phases":453,"briefSummary":455,"conditions":456,"keywords":462,"overallStatus":99,"whyStopped":33,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},{"fullName":5,"class":6},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",[8,15,22,29],{"label":9,"type":10,"description":11,"interventionNames":12},"High-dose methylprednisolone","EXPERIMENTAL","Intravenous methylprednisolone at an initial dose of 10 mg\u002Fkg\u002Fday for 3 days, 5 mg\u002Fkg\u002Fday on day 4.",[13,14],"Drug: High-dose methylprednisolone","Drug: Prednisolone",{"label":16,"type":10,"description":17,"interventionNames":18},"Equine anti-thymocyte globulin","Intravenous equine anti-thymocyte globulin at a dose of 40 mg\u002Fkg\u002Fday for 4 days.",[19,14,20,21],"Drug: Equine anti-thymocyte globulin","Drug: Diphenhydramine","Drug: Methylprednisolone",{"label":23,"type":24,"description":25,"interventionNames":26},"Supportive care","PLACEBO_COMPARATOR","Supportive care will be administered as determined by the clinical team at participating clinical sites in accordance with their local practices and standards.",[27,28],"Drug: Placebo for prednisolone","Drug: Placebo for infusions",{"label":30,"type":31,"description":32,"interventionNames":33},"Observational Cohort","NO_INTERVENTION","This study includes a prospective observational cohort study of patients with Pediatric Acute Liver Failure who meet the randomized controlled trial eligibility criteria and are willing to provide longitudinal observational data. Patients who provide consent will receive the enrolling institution's standard of care and will be followed for up to 90-days for clinical (observational) assessments and biospecimen collection for the biorepository.",null,[35,41,46,52,56,62,68],{"type":36,"name":9,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Subjects in the high-dose methylprednisolone arm will receive an initial dose of methylprednisolone IV 10 mg\u002Fkg\u002Fday for 3 days and 5 mg\u002Fkg\u002Fday on Day 4. Normal saline will be used as placebo pre-medications and infusions given at the same volume and duration as the eATG infusions.",[9],[40],"Solu-Medrol",{"type":36,"name":16,"description":42,"armGroupLabels":43,"otherNames":44},"Subjects will receive eATG IV 40 mg\u002Fkg\u002Fday on Days 1- 4. Day 1 eATG infusion is run over 8 hours and Day 2-4 infusions are run over 4 hours.",[16],[45],"ATGAM",{"type":36,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Prednisolone","Subjects will receive prednisolone 1 mg\u002Fkg on Days 5-13 followed by a gradual taper with discontinuation at 42 Days as indicated below.\n\nDays 5 - 13 Prednisolone PO 1 mg\u002Fkg\u002Fday (max 50 mg\u002Fday)\n\nDays 14- 20 Prednisolone PO 0.5 mg\u002Fkg\u002Fday (max 25 mg\u002Fday)\n\nDays 21 - 27 Prednisolone PO 0.3 mg\u002Fkg\u002Fday (max 15 mg\u002Fday)\n\nDays 28 - 34 Prednisolone PO 0.1 mg\u002Fkg\u002Fday (max 5 mg\u002Fday)\n\nDays 35 - 41 Prednisolone PO 0.1 mg\u002Fkg every OTHER day (max 5 mg every other day)\n\nDay 42 Discontinue",[16,9],[51],"15 mg\u002FmL oral solution National Drug Code: 0121-0885-08",{"type":36,"name":53,"description":54,"armGroupLabels":55,"otherNames":33},"Placebo for prednisolone","Subjects will receive 1 mg\u002Fkg\u002Fday of oral placebo for prednisolone on days 5-13 followed by a gradual taper to discontinuation at 42 days as indicated below. Subjects receiving oral placebo will be given a solution that closely resembles the treatment drug.\n\nDays 5 - 13 Placebo for Prednisolone PO 1 mg\u002Fkg\u002Fday (max 50 mg\u002Fday)\n\nDays 14- 20 Placebo for Prednisolone PO 0.5 mg\u002Fkg\u002Fday (max 25 mg\u002Fday)\n\nDays 21 - 27 Placebo for Prednisolone PO 0.3 mg\u002Fkg\u002Fday (max 15 mg\u002Fday)\n\nDays 28 - 34 Placebo for Prednisolone PO 0.1 mg\u002Fkg\u002Fday (max 5 mg\u002Fday)\n\nDays 35 - 41 Placebo for Prednisolone PO 0.1 mg\u002Fkg every OTHER day (max 5 mg every other day)\n\nDay 42 Discontinue",[23],{"type":36,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Placebo for infusions","Subjects randomized to the supportive care alone arm will receive normal saline in place of all study treatments (skin test, premedication and IV infusions) on Days 1-4 given at the same volume and duration as the eATG infusions.",[23],[61],"0.9% Sodium chloride",{"type":36,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Diphenhydramine","Subjects in the eATG arm will receive pre-treatment medication diphenhydramine IV 1 mg\u002Fkg prior to start of eATG infusion.",[16],[67],"Benadryl",{"type":36,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Methylprednisolone","Subjects in the eATG arm will receive pre-treatment medication methylprednisolone IV 1 mg\u002Fkg prior to start of eATG infusion.",[16],[40],[74,78,81,84],{"name":75,"affiliation":76,"role":77},"Estella M Alonso, MD","Ann & Robert H Lurie Children's Hospital of Chicago","PRINCIPAL_INVESTIGATOR",{"name":79,"affiliation":80,"role":77},"Valerie L Durkalski-Mauldin, PhD","Medical University of South Carolina",{"name":82,"affiliation":5,"role":83},"Ed Doo, MD","STUDY_DIRECTOR",{"name":85,"affiliation":5,"role":83},"Averell Sherker, MD",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":33,"email":91},"Katie Neighbors, MPH","CONTACT","312-227-4557","kneighbors@luriechildrens.org",{"name":93,"role":89,"phone":94,"phoneExt":33,"email":95},"Caitlin Schaffner, MPH","843-792-6588","schaffne@musc.edu",[97,117,132,147,157,173,183,193,209,225,242,258,273,282,294,304,320,329,345,360,376,392,407,417],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-118.24368,34.05223,{"lat":109,"lon":108},[112,116],{"name":113,"role":89,"phone":114,"phoneExt":33,"email":115},"Beth Carter, MD","323-361-5454","becarter@chla.usc.edu",{"name":113,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":118,"status":99,"city":119,"state":101,"zip":120,"country":103,"countryCode":104,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Lucile Packard Children's Hospital","Palo Alto","94304",{"type":106,"coordinates":122},[123,124],-122.14302,37.44188,{"lat":124,"lon":123},[127,131],{"name":128,"role":89,"phone":129,"phoneExt":33,"email":130},"Amrita Narang, MD","312-498-5294","anarang@stanford.edu",{"name":128,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":133,"status":99,"city":134,"state":101,"zip":135,"country":103,"countryCode":104,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Rady Children's Hospital","San Diego","92123",{"type":106,"coordinates":137},[138,139],-117.16472,32.71571,{"lat":139,"lon":138},[142,146],{"name":143,"role":89,"phone":144,"phoneExt":33,"email":145},"Amber Hildreth, DO","858-966-1700","anhildreth@health.ucsd.edu",{"name":143,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":148,"status":149,"city":150,"state":101,"zip":151,"country":103,"countryCode":104,"cosmosGeoPoint":152,"geoPoint":156,"contacts":33},"University of California San Francisco Benioff Children's Hospital","WITHDRAWN","San Francisco","94158",{"type":106,"coordinates":153},[154,155],-122.41942,37.77493,{"lat":155,"lon":154},{"facility":158,"status":99,"city":159,"state":160,"zip":161,"country":103,"countryCode":104,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":106,"coordinates":163},[164,165],-104.83192,39.72943,{"lat":165,"lon":164},[168,172],{"name":169,"role":89,"phone":170,"phoneExt":33,"email":171},"Shikha Sundaram, MD","720-777-6669","shikha.sundaram@childrenscolorado.org",{"name":169,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":174,"status":149,"city":175,"state":176,"zip":177,"country":103,"countryCode":104,"cosmosGeoPoint":178,"geoPoint":182,"contacts":33},"Yale New Haven Children's Hospital","New Haven","Connecticut","06510",{"type":106,"coordinates":179},[180,181],-72.92816,41.30815,{"lat":181,"lon":180},{"facility":184,"status":149,"city":185,"state":186,"zip":187,"country":103,"countryCode":104,"cosmosGeoPoint":188,"geoPoint":192,"contacts":33},"Children's Healthcare of Atlanta - Arthur M. Blank Hospital","Atlanta","Georgia","30322",{"type":106,"coordinates":189},[190,191],-84.38798,33.749,{"lat":191,"lon":190},{"facility":194,"status":99,"city":195,"state":196,"zip":197,"country":103,"countryCode":104,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":106,"coordinates":199},[200,201],-87.65005,41.85003,{"lat":201,"lon":200},[204,208],{"name":205,"role":89,"phone":206,"phoneExt":33,"email":207},"Catherine Chapin, MD","312-227-5511","cchapin@luriechildrens.org",{"name":205,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":210,"status":99,"city":211,"state":212,"zip":213,"country":103,"countryCode":104,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Riley Hospital for Children","Indianapolis","Indiana","46202",{"type":106,"coordinates":215},[216,217],-86.15804,39.76838,{"lat":217,"lon":216},[220,224],{"name":221,"role":89,"phone":222,"phoneExt":33,"email":223},"Kyla Tolliver, MD","317-944-3774","kmtolliv@iu.edu",{"name":221,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":226,"status":99,"city":227,"state":228,"zip":229,"country":103,"countryCode":104,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Children's Hospital Boston","Boston","Massachusetts","02115",{"type":106,"coordinates":231},[232,233],-71.05977,42.35843,{"lat":233,"lon":232},[236,240],{"name":237,"role":89,"phone":238,"phoneExt":33,"email":239},"Scott Elisofon","617-355-5837","Scott.Elisosfon@childrens.harvard.edu",{"name":241,"role":77,"phone":33,"phoneExt":33,"email":33},"Scott Elisofon, MD",{"facility":243,"status":99,"city":244,"state":245,"zip":246,"country":103,"countryCode":104,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":106,"coordinates":248},[249,250],-94.57857,39.09973,{"lat":250,"lon":249},[253,257],{"name":254,"role":89,"phone":255,"phoneExt":33,"email":256},"Ryan Fischer, MD","816-302-3410","rtfischer@cmh.edu",{"name":254,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":259,"status":99,"city":260,"state":245,"zip":261,"country":103,"countryCode":104,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"St. Louis Children's Hospital","St Louis","63110",{"type":106,"coordinates":263},[264,265],-90.19789,38.62727,{"lat":265,"lon":264},[268,272],{"name":269,"role":89,"phone":270,"phoneExt":33,"email":271},"David Rudnick, MD PhD","314-286-2832","rudnick_d@wustl.edu",{"name":269,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":274,"status":149,"city":275,"state":275,"zip":276,"country":103,"countryCode":104,"cosmosGeoPoint":277,"geoPoint":281,"contacts":33},"The Mount Sinai Medical Center","New York","10029",{"type":106,"coordinates":278},[279,280],-74.00597,40.71427,{"lat":280,"lon":279},{"facility":283,"status":99,"city":275,"state":275,"zip":284,"country":103,"countryCode":104,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"NYP Morgan Stanley Children's Hospital","10032",{"type":106,"coordinates":286},[279,280],{"lat":280,"lon":279},[289,293],{"name":290,"role":89,"phone":291,"phoneExt":33,"email":292},"Steven Lobritto, MD","212-305-3000","sjl12@cumc.columbia.edu",{"name":290,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":295,"status":149,"city":296,"state":297,"zip":298,"country":103,"countryCode":104,"cosmosGeoPoint":299,"geoPoint":303,"contacts":33},"Duke University Medical Center - Duke Children's","Durham","North Carolina","27710",{"type":106,"coordinates":300},[301,302],-78.89862,35.99403,{"lat":302,"lon":301},{"facility":305,"status":99,"city":306,"state":307,"zip":308,"country":103,"countryCode":104,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":106,"coordinates":310},[311,312],-84.51439,39.12711,{"lat":312,"lon":311},[315,319],{"name":316,"role":89,"phone":317,"phoneExt":33,"email":318},"Anna Peters, MD PhD","319-321-9720","Anna.Peters@cchmc.org",{"name":316,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":321,"status":149,"city":322,"state":307,"zip":323,"country":103,"countryCode":104,"cosmosGeoPoint":324,"geoPoint":328,"contacts":33},"Cleveland Clinic Children's","Cleveland","44195",{"type":106,"coordinates":325},[326,327],-81.69541,41.4995,{"lat":327,"lon":326},{"facility":330,"status":99,"city":331,"state":332,"zip":333,"country":103,"countryCode":104,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"The Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":106,"coordinates":335},[336,337],-75.16362,39.95238,{"lat":337,"lon":336},[340,344],{"name":341,"role":89,"phone":342,"phoneExt":33,"email":343},"Kathleen Loomes, MD","267-426-7223","LOOMES@email.chop.edu",{"name":341,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":346,"status":99,"city":347,"state":332,"zip":348,"country":103,"countryCode":104,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Children's Hospital of Pittsburgh","Pittsburgh","15224",{"type":106,"coordinates":350},[351,352],-79.99589,40.44062,{"lat":352,"lon":351},[355,359],{"name":356,"role":89,"phone":357,"phoneExt":33,"email":358},"James Squires, MD","412-692-5180","james.squires2@chp.edu",{"name":356,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":361,"status":99,"city":362,"state":363,"zip":364,"country":103,"countryCode":104,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Children's Hospital Vanderbilt","Nashville","Tennessee","37232",{"type":106,"coordinates":366},[367,368],-86.78444,36.16589,{"lat":368,"lon":367},[371,375],{"name":372,"role":89,"phone":373,"phoneExt":33,"email":374},"Saeed Mohammad, MD","615-322-7449","saeed.mohammad@vumc.org",{"name":372,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":377,"status":99,"city":378,"state":379,"zip":380,"country":103,"countryCode":104,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"UT Southwestern Medical Center Children's Health","Dallas","Texas","75235",{"type":106,"coordinates":382},[383,384],-96.80667,32.78306,{"lat":384,"lon":383},[387,391],{"name":388,"role":89,"phone":389,"phoneExt":33,"email":390},"Norberto Rodriguez-Baez, MD","214-456-7436","Norberto.Rodriguez-Baez@UTSouthwestern.edu",{"name":388,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":393,"status":99,"city":394,"state":379,"zip":395,"country":103,"countryCode":104,"cosmosGeoPoint":396,"geoPoint":400,"contacts":401},"Texas Children's Hospital","Houston","77030",{"type":106,"coordinates":397},[398,399],-95.36327,29.76328,{"lat":399,"lon":398},[402,406],{"name":403,"role":89,"phone":404,"phoneExt":33,"email":405},"Anna Banc-Husu, MD MSCI","832-822-3624","anna.banc-husu@bcm.edu",{"name":403,"role":77,"phone":33,"phoneExt":33,"email":33},{"facility":408,"status":149,"city":409,"state":410,"zip":411,"country":103,"countryCode":104,"cosmosGeoPoint":412,"geoPoint":416,"contacts":33},"Primary Children's Medical Center","Salt Lake City","Utah","84112",{"type":106,"coordinates":413},[414,415],-111.89105,40.76078,{"lat":415,"lon":414},{"facility":418,"status":99,"city":419,"state":420,"zip":421,"country":103,"countryCode":104,"cosmosGeoPoint":422,"geoPoint":426,"contacts":427},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":106,"coordinates":423},[424,425],-122.33207,47.60621,{"lat":425,"lon":424},[428,432],{"name":429,"role":89,"phone":430,"phoneExt":33,"email":431},"Pamela Valentino, MD","206-987-1095","pamela.valentino@seattlechildrens.org",{"name":429,"role":77,"phone":33,"phoneExt":33,"email":33},{"type":434,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[436],{"name":76,"class":437},"OTHER","100428681","phase-2-treatment-for-immune-mediated-pathophysiology-100428681",false,"NCT04862221","TReatment for ImmUne Mediated PathopHysiology","A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial With Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failure in Pediatric Patients","TRIUMPH","Inclusion Criteria:\n\n1. Patient with liver injury of ≤ 6 weeks duration resulting in an international normalization ratio (INR) of ≥ 1.5 or \\\u003C 2.0 (not corrected by vitamin K) with evidence of hepatic encephalopathy (HE), INR of ≥ 1.5 or \\\u003C 2.0 for at least 7 days duration without evidence of HE or INR ≥ 2.0 without evidence of HE.\n2. Age is greater than or equal to 1 year and less than 18 years of age.\n3. Patient or their legally authorized representative(s) (LAR) must consent (and assent, if applicable) to be in the study and must have signed and dated an approved informed consent form which conforms to federal and institutional guidelines.\n4. Females of reproductive potential should not plan on conceiving children during the study and must agree to use a medically accepted form of contraception.\n\nExclusion Criteria:\n\n1. Evidence of active infection with Hepatitis A, B, C, E or evidence of acute herpes simplex virus (HSV) or adenovirus infection\n2. Travel within the past 3 months to an area highly endemic for Hepatitis E\n3. Diagnosis of hemophagocytic lymphohistiocytosis (HLH) Note: Patients with a history of consanguinity and\u002For central nervous system (CNS) dysfunction that is exaggerated compared to the degree of liver dysfunction (as judged by the site investigator) will not be enrolled until results of rapid genetic testing are available. Turn-around time for genetic testing results is estimated to be 72-96 hours.\n4. Aplastic anemia as defined by standardized criteria \\[1\\] diagnosed prior to enrollment\n5. Diagnosis of autoimmune Hepatitis (AIH)\n6. Diagnosis of acute Wilson disease\n7. Diagnosis of inborn error of metabolism Note: Suspicion of metabolic disease is not an exclusion for entry into the Trial.\n8. Diagnosis of acute drug or toxin-induced liver injury\n9. History of recreational drug use within the past 4 weeks\n10. Therapy with an immunosuppressive agent, including chemotherapy, biological therapies or an experimental drug or device within the past 6 weeks\n11. Liver injury due to ischemia\n12. Liver dysfunction diagnosed more than 6 weeks prior to screening\n13. History of allergy to horse dander\n14. Sepsis\n15. Imminent risk of death as judged by the clinical site investigator, including but not limited to; signs of cerebral herniation at the time of enrollment and presence of intractable arterial hypotension\n16. Solid organ or stem cell transplant recipient\n17. Pregnant or breast-feeding at the time of proposed study entry\n18. Clinical AIDS or HIV positive\n19. History of any form of malignant neoplasm and\u002For tumors treated within five years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease\n20. Received a live-virus vaccine within 4 weeks of study entry\n21. Patients with positive respiratory secretion testing for respiratory viral infection including SARS-CoV-2, influenza and respiratory syncytial virus only if they also have declining respiratory function\n22. Psychiatric or addictive disorders that would preclude obtaining informed consent\u002Fassent\n23. Patient is unwilling or unable to adhere with study requirements and procedures\n24. Currently receiving other experimental therapies","ALL","1 Year","18 Years",{"count":450,"type":451},163,"ESTIMATED","INTERVENTIONAL",[454],"PHASE2","TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition.",[457,458,459,460,461],"Acute Liver Failure","Fulminant Hepatic Failure","Hepatic Encephalopathy","Acute Liver Injury","Immune Dysregulation",[463,464,465,466],"hepatic insufficiency","liver diseases","liver failure","anti-thymocyte agents","2026-05-11",{"date":469,"type":470},"2026-05-14","ACTUAL",{"date":472,"type":470},"2022-02-09",{"date":474,"type":451},"2027-02",{"name":5,"class":6},24]