[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650235":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":85,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Children's Healthcare of Atlanta","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Cohort","EXPERIMENTAL","Participants on the Intervention Cohort will receive a combination of immunomodulatory regimen using emapalumab and methylprednisolone (or prednisone equivalent), aimed at controlling severe immune-mediated hepatitis and preventing progression to liver failure.\n\nParticipants will be monitored closely for clinical improvement, laboratory normalization, and adverse events throughout the 56-day treatment period, with continued follow-up through Day 180 to assess long-term outcomes, including relapse, liver failure, survival, and safety.",[13],"Drug: Emapalumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Emapalumab","Participants on the Intervention Cohort will receive a combination of immunomodulatory regimen using emapalumab and methylprednisolone (or prednisone equivalent), aimed at controlling severe immune-mediated hepatitis and preventing progression to liver failure.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Shanmuganathan Chandrakasan, MD","CONTACT","404-727-8877","Shanmuganathan.Chandrakasan@emory.edu",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Maria Frazer","4047856162","maria.frazer@choa.org",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Arthur M. Blank Children's Healthcare of Atlanta","Atlanta","Georgia","30322","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-84.38798,33.749,{"lat":43,"lon":42},[46,47],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":48,"role":24,"phone":20,"phoneExt":20,"email":49},"Kate Silvis","Katherine.Silvis@choa.org",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[53],{"name":54,"class":55},"Sobi, Inc.","INDUSTRY","100650235","phase-2-severe-hepatitis-intervention-with-emapalumab-for-liver-disease-100650235",false,"NCT07744919","Severe Hepatitis Intervention With Emapalumab for Liver Disease","A Phase 2 Study of Emapalumab for Prevention of Liver Failure in Pediatric Indeterminate Severe Hepatitis Associated With T-Cell Activation: Severe Hepatitis Intervention With Emapalumab for Liver Disease","SHIELD","Inclusion Criteria (Screening Cohort):\n\n* Age: Participants must be ≥ 1 year of age at the time of screening.\n* Evidence of Severe Hepatic Injury of all etiology (not just iSH\u002F iSH-T): Serum alanine aminotransferase (ALT) ≥ 1000 U\u002FL documented within 7 days prior to enrollment.\n\nExclusion Criteria (Screening Cohort):\n\n* Any condition impairing informed consent\u002Fassent or protocol compliance\n\nInclusion Criteria (Intervention Cohort; patients who meet Intervention Cohort eligibility can bypass Screening Cohort enrollment):\n\n* Steroid-refractory, steroid-dependent, or relapse of hepatitis after stopping steroids and have an Indeterminate etiology of hepatitis based on standard of care, age appropriate evaluation\n* Age: ≥ 1 year\n* ALT ≥ 1000 U\u002FL prior to initiation of any immune modulatory therapy\n* Evidence of T-cell activation at initial diagnosis, as indicated by one of the following:\n\n  * sIL2R \\> 2× upper limit of normal (ULN)\n  * CXCL9 \\> 5× ULN\n  * CD8+ T-cell infiltration in the liver\n* INR \\\u003C 2.0 without evidence of hepatic encephalopathy\n\nExclusion Criteria (Intervention Cohort; patients who meet Intervention Cohort eligibility can bypass Screening Cohort enrollment):\n\n* Patients with known Liver failure (defined as INR \\>2 on two consecutive occasions without hepatic encephalopathy (HE), or INR ≥1.5 with evidence of HE)\n* Evidence of chronic liver disease or parenchymal nodularity as demonstrated on imaging (US, CT, or MRI)\n* Evidence of hepatic encephalopathy\n* Severe acquired aplastic anemia at presentation\n* Organ dysfunction assessment defined below:\n\n  * Renal dysfunction: eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² or\n  * Mechanical Ventilation\n* Persistent systemic infection despite appropriate antimicrobial therapy\n* Active infection with Hepatitis A, B, C, HIV, or herpes simplex virus\n* Active mycobacteria (typical and atypical), Histoplasma Capsulatum, Herpes zoster infections.\n* Patients with positive respiratory viral infection, including adenovirus, rhinovirus\u002Fenterovirus, SARS-CoV-2, influenza, and respiratory syncytial virus, only if they also have declining respiratory function needing positive pressure support. Suspected primary hemophagocytic lymphohistiocytosis based on patients with a history of consanguinity and\u002For central nervous system dysfunction or other clinical manifestations that is exaggerated compared to the degree of liver dysfunction (as judged by the site investigator and study team)\n* Diagnosis of Autoimmune Hepatitis, Wilson Disease, inborn error of metabolism, acute drug or toxin-induced liver injury, or ischemic liver injury\n* History of severe hypersensitivity or allergy to any component of this study regimen\n* History of confirmed malignancy\n* History of recreational drug use within the past 4 weeks, excluding cannabinoids\n* Therapy with an immunosuppressive agent or an experimental drug within the past 6 weeks\n* Pregnant, planning to become pregnant during study window, or breastfeeding at time of study entry\n* Patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method (e.g. hormonal contraceptives, intrauterine device, or double-barrier method) for the duration of their study participation. Patients must maintain adequate contraception for at least 4 weeks after their last dose of emapalumab.\n* Live-virus vaccination within 4 weeks of study entry or anticipated need for a live or live attenuated vaccine within 4 weeks after the last dose of emapalumab\n* Peceived Bacillus Calmette-Guerin vaccine within 12 weeks prior to screening\n* Patient or parent\u002Fguardian unable to give informed consent or unable to comply with the treatment protocol\n* Prisoners will be excluded","ALL","1 Year","30 Years",{"count":68,"type":69},28,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","The goal of this study is to see whether a medicine called emapalumab, a monoclonal antibody, is safe and works well for patients aged 1 year and older who have indeterminate severe hepatitis with T-cell activation and have not responded well to steroids or still need them.\n\nThis study has a Screening Cohort and an Intervention Cohort.\n\nThe Screening Cohort will enroll patients with severe hepatitis of all etiologies to observe and collect research samples. Patients enrolled on the Screening Cohort will be asked to participate on the Intervention Cohort if they develop steroid-refractory\u002F dependent indeterminate severe hepatitis (iSH-T). Additionally, patients may bypass the Screening Cohort and enroll directly in the Intervention Cohort if they already meet its eligibility criteria. Patients in the Intervention Cohort will be treated with emapalumab.",[75],"Hepatitis",[75,17,77,78,79,80,81,82,83,84],"iSH-T","anti-IFN-gamma monoclonal antibody","Severe Hepatitis Associated with T-Cell Activation","Severe Hepatitis","Steroid-refractory hepatitis","steroid-dependent hepatitis","relapse hepatitis","Severe Hepatic Injury","NOT_YET_RECRUITING","2026-07-31",{"date":88,"type":89},"2026-08-04","ACTUAL",{"date":91,"type":69},"2026-09-01",{"date":93,"type":69},"2032-09",{"name":5,"class":6},1]