SIPLIZUMAB in AILD & LT

Status Not yet recruiting

Clinical Trial 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 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.

Clinical Trial 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 0.6 mg/kg/dose 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06455280
Study type	Interventional
Source	Columbia University
Contact	Theresa Lukose, PharmD
Phone	212-305-3839
Email	tt2103@cumc.columbia.edu
Status	Not yet recruiting
Phase	Phase 1
Start date	June 1, 2024
Completion date	March 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05793983` - S100A8/A9 and Innate Immunity in Liver Disease
Completed	`NCT04604860` - Use of EL-FIT App to Promote Physical Activity	N/A
Recruiting	`NCT05928624` - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients	N/A
Active, not recruiting	`NCT01438970` - Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function	Phase 2
Recruiting	`NCT05998330` - LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease	N/A
Completed	`NCT04581369` - Cirrhosis Medical Home	N/A
Withdrawn	`NCT04244877` - Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility	Phase 3
Recruiting	`NCT04588077` - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis	Phase 4
Recruiting	`NCT05538962` - Longitudinal Monitoring of Inflammation in Cirrhosis	N/A
Completed	`NCT04082780` - Rifamycin in Minimal Hepatic Encephalopathy	Phase 2
Completed	`NCT03850977` - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Active, not recruiting	`NCT03736265` - Carvedilol for Prevention of Esophageal Varices Progression	N/A
Recruiting	`NCT04530760` - Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Recruiting	`NCT05093218` - Effect of Branch Chain Amino Acid Therapy on Sarcopenia in Children With Chronic Liver Disease.	N/A
Recruiting	`NCT03437876` - Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis	N/A
Recruiting	`NCT05604274` - Longitudinal Monitoring of Stool Characteristics
Recruiting	`NCT04867954` - Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
Completed	`NCT04643795` - Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects	Phase 1
Active, not recruiting	`NCT02344680` - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed	`NCT04121520` - Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SIPLIZUMAB in AILD and LT — SET-SAIL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms