[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551068":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Columbia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open Label","EXPERIMENTAL","subjects will receive 0.6 mg\u002Fkg\u002Fdose intravenously on the day of transplant (Day 0) intraoperatively and on post-transplant Day 4.",[13],"Drug: Siplizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Siplizumab","Siplizumab is an anti-CD2 monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Elizabeth Verna, MD","Columbia University Irving Medical Center\u002F New York Presbyterian Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Theresa Lukose, PharmD","CONTACT","212-305-3839","tt2103@cumc.columbia.edu",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Amanda Alonso, MHA","212-342-0261","aa2974@cumc.columbia.edu",[37],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Columbia University Irving Medical Center\u002FNewYork-Presbyterian Hospital","RECRUITING","New York","10032","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-74.00597,40.71427,{"lat":48,"lon":47},[51,52],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Elizabeth C. Verna","Frank Cardile Associate Professor of Medicine",[58],{"name":59,"class":60},"ITB-Med LLC","INDUSTRY","100551068","phase-1-a-study-of-siplizumab-in-aild-and-lt-patients-100551068",false,"NCT06455280","A Study of SIPLIZUMAB in AILD and LT Patients","A 12-Month, Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Siplizumab as Induction Therapy in Patients With Autoimmune Liver Diseases Undergoing Liver Transplantation (SET-SAIL)","SET-SAIL","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age ≥ 18 years old\n3. Clinical diagnosis of AIH and\u002For PSC\n4. Listed for liver transplantation\n5. Epstein-Barr virus (EBV) seropositive within 12 months of screening\n\nExclusion Criteria:\n\n1. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis\n2. Prior transplant\n3. Listed for multiorgan transplant\n4. Acute liver failure\n5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma\n6. Other investigational products in the last 30 days or 5 half lives\n7. Pregnant\u002Flactating or unwilling to use contraception\n8. Leukopenia (WBC less than 2,000\u002Fmm3\n9. Absolute lymphocyte count \\\u003C 200\u002Fmm3\n10. Sero-positive for HIV-1\n11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)\n12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)\n13. Alcohol use exceeding 30g\u002Fday for men or 20g\u002Fday for women, and\u002For known phosphatidylethanol (PETH) level \\>80 in the 3 months prior to LT\n14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)\n15. Receipt of any live-attenuated vaccine within 2 months of transplant.\n\nADDITIONAL exclusion criteria to be reviewed at the time of transplant\n\n1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \\\u003C 30 at the time of LT\n2. Model for end-stage liver disease (MELD)-Na score \\>30\n3. Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ","ALL","18 Years",{"count":72,"type":73},8,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT.\n\nUp to eight (8) subjects will receive siplizumab 0.6 mg\u002Fkg\u002Fdose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses.\n\nAll subjects will be followed in the study for 12 months post-LT.",[79,80,81,82,83,84],"Autoimmune Liver Disease","Liver Transplant Disorder","Autoimmune Hepatitis","Primary Sclerosing Cholangitis","End Stage Liver DIsease","Cirrhosis, Liver",[79,80,81,82,83,84],"2025-11-19",{"date":88,"type":89},"2025-11-24","ACTUAL",{"date":91,"type":89},"2024-09-11",{"date":93,"type":73},"2028-03-31",{"name":55,"class":6},1]