Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
SIPLIZUMAB in AILD and LT
Sponsor:
Elizabeth C Verna
Organization:
Columbia University
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SET-SAIL
Brief Summary:
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-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
Up to eight 8 subjects will receive siplizumab 06 mgkgdose on the day of transplant Day 0 and Day 4 post-transplant for a total of two doses
All subjects will be followed in the study for 12 months post-LT
Up to eight 8 subjects will receive siplizumab 06 mgkgdose on the day of transplant Day 0 and Day 4 post-transplant for a total of two doses
All subjects will be followed in the study for 12 months post-LT
Detailed Description:
The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with PSC or 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
Adult patients 18 years of age and older listed for LT with the specific AILD diagnoses of PSC or AIH
All subjects will receive 06 mgkgdose intravenously on the day of transplant Day 0 intraoperatively and on post-transplant Day 4
Participation in this study will last approximately 15 months 3 months on the LT waitlist up to 12 months participation post-LT
Adult patients 18 years of age and older listed for LT with the specific AILD diagnoses of PSC or AIH
All subjects will receive 06 mgkgdose intravenously on the day of transplant Day 0 intraoperatively and on post-transplant Day 4
Participation in this study will last approximately 15 months 3 months on the LT waitlist up to 12 months participation post-LT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None