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NCT06455280 · ClinicalTrials.gov registry record · Phase 1
A Study of SIPLIZUMAB in AILD and LT Patients
A Phase 1 study of Cirrhosis, Liver and Primary Sclerosing Cholangitis, sponsored by Elizabeth C. Verna.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT06455280 is a Phase 1 study of Cirrhosis, Liver and Primary Sclerosing Cholangitis that is actively recruiting participants, run by Elizabeth C. Verna. The registered enrollment target is 8 participants, below the 242-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06455280, a Phase 1 study of Cirrhosis, Liver and Primary Sclerosing Cholangitis, is actively recruiting participants, sponsored by Elizabeth C. Verna.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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-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. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose 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.
Conditions Studied
Interventions
- DRUG Siplizumab
Study Locations (1)
New York
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455280
The ClinicalTrials.gov registry entry for NCT06455280 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (97% lower). The listed sponsor is Elizabeth C. Verna, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 1 intervention - of which Siplizumab is the first listed.
NCT06455280 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06455280 about?
NCT06455280 is a clinical study titled "A Study of SIPLIZUMAB in AILD and LT Patients". 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 a...
What is the current status of trial NCT06455280?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2024-09-11. Estimated completion is 2028-03-31.
What conditions does trial NCT06455280 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Primary Sclerosing Cholangitis, End Stage Liver DIsease, Autoimmune Hepatitis, Liver Transplant Disorder.
What interventions are being tested in trial NCT06455280?
The interventions under investigation include: Siplizumab (DRUG).
Who is sponsoring clinical trial NCT06455280?
This trial is sponsored by Elizabeth C. Verna, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06455280 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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