[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06455280":3,"trial-entities:NCT06455280":116,"trial-summary:NCT06455280":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":75,"locations":78,"central_contacts":96,"overall_officials":102,"references":105,"see_also_links":106},"NCT06455280","AAAU7303","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)","RECRUITING","2028-03-31","2025-11","2025-11-24","2024-09-11","Elizabeth C. Verna","OTHER",false,"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.","The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with primary sclerosing cholangitis (PSC) or autoimmune hepatitis (AIH) undergoing liver transplantation. Induction immunosuppression drugs are very potent anti-rejection drugs that are given immediately after transplantation to prevent rejection. Siplizumab is investigational, meaning it has not yet been approved for market use for this disease condition by the United States Food and Drug Administration (FDA).\n\nAdult patients (18 years of age and older) listed for LT with the specific AILD diagnoses of PSC or AIH\n\nAll subjects will receive 0.6 mg\u002Fkg\u002Fdose intravenously on the day of transplant (Day 0) intraoperatively and on post-transplant Day 4.\n\nParticipation in this study will last approximately 15 months (\\~ 3 months on the LT waitlist, up to 12 months participation post-LT)",[19,20,21,22,23,24],"Autoimmune Liver Disease","Liver Transplant Disorder","Autoimmune Hepatitis","Primary Sclerosing Cholangitis","End Stage Liver DIsease","Cirrhosis, Liver",[19,20,21,22,23,24],"INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},8,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Open Label",[41],{"measure":42,"description":43,"timeFrame":44},"Serious infection in the first month post-transplant,","viral, bacterial or fungal infection that leads to readmission, prolonged hospitalization, reoperation, intensive care unit admission, graft loss or death.","1 Month post-transplant",[46,50,53,56,59,62,65],{"measure":47,"description":48,"timeFrame":49},"Incidence of immune-mediated liver injury","biopsy proven acute rejection (BPAR), or recurrent AILD","12 month Post-transplant",{"measure":51,"description":52,"timeFrame":49},"Incidence of graft loss or death","Loss of liver allograft or incidence of mortality",{"measure":54,"description":55,"timeFrame":49},"Incidence of BPAR","biopsy proven acute rejection within 12 Month post-transplant",{"measure":57,"description":58,"timeFrame":49},"Incidence of treated BPAR","biopsy proven acute rejection that requires treatment within 12 Month post-transplant",{"measure":60,"description":61,"timeFrame":49},"Incidence of refractory BPAR","biopsy proven acute rejection within 12 Month post-transplant that is not responsive to treatment",{"measure":63,"description":64,"timeFrame":49},"Incidence of development of donor specific antibodies (DSA)","Donor specific antibodies within 12 Month Post-transplant",{"measure":66,"description":67,"timeFrame":49},"Incidence of recurrent AILD","based upon histology for autoimmune hepatitis \\[AIH\\] and histology and\u002For imaging for primary sclerosing cholangitis \\[PSC\\]","ALL","18 Years",null,{"inclusion":72,"exclusion":73,"raw_text":74},[],[],"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",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"status":8,"city":81,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":93},"Columbia University Irving Medical Center\u002FNewYork-Presbyterian Hospital","New York","10032","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Theresa Lukose, PharmD","CONTACT","212-305-3839","tt2103@cumc.columbia.edu",{"name":91,"role":92},"Elizabeth Verna, MD","PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},40.71427,-74.00597,[97,98],{"name":86,"role":87,"phone":88,"email":89},{"name":99,"role":87,"phone":100,"email":101},"Amanda Alonso, MHA","212-342-0261","aa2974@cumc.columbia.edu",[103],{"name":91,"affiliation":104,"role":92},"Columbia University Irving Medical Center\u002F New York Presbyterian Hospital",[],[107,110,113],{"label":108,"url":109},"kwong, A., et al., OPTN\u002FSRTR 2018 Annual Data Report: Liver. Am J Transplant, 2020. 20 Suppl s1: p. 193- 299.","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F31898413\u002F",{"label":111,"url":112},"Qian, J., et al., Studies on the induction of tolerance to alloantigens. I. The abrogation of potentials for delayed-type-hypersensitivity response to alloantigens by portal venous inoculation with allogeneic cells. J Immunol, 1985. 134(6): p. 3656-61.","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F2580893\u002F",{"label":114,"url":115},"gugenheim, J., et al., Delayed rejection of heart allografts in hypersensitized rats by extracorporeal donorspecific liver hemoperfusion. Transplantation, 1986. 41(3): p. 398-400.","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F3513399\u002F",{"nct_id":4,"conditions":117,"biomarkers":118},[21,22],[119],"X-linked Lymphoproliferative Syndrome 1",{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an open-label study, meaning both you and the study team will know you are receiving Siplizumab. It plans to include up to 8 participants.","completed","Siplizumab for Autoimmune Liver Disease Patients Undergoing Liver Transplant","This study is testing a drug called Siplizumab in people with autoimmune liver diseases (like autoimmune hepatitis and primary sclerosing cholangitis) who are having a liver transplant. Siplizumab is a type of medicine called a monoclonal antibody that targets certain immune cells to help prevent the body from rejecting the new liver. Researchers want to see how safe Siplizumab is when given right after a liver transplant. The study plans to include up to 8 participants. The main goal is to track any serious infections in the first month after transplant. To join, you must be at least 18 years old, have one of these autoimmune liver diseases, be listed for a liver transplant, and have tested positive for Epstein-Barr virus (EBV) in the last year. The study status is currently unclear.","The study will measure serious infections in the first month after your transplant. Your participation will last up to 12 months post-transplant.",132,"You would receive Siplizumab intravenously (through a vein) on the day of your transplant and again four days later. Your participation will last approximately 15 months, including time on the transplant waitlist and up to 12 months after your transplant.","Not stated in the trial record.",[36],"v2"]