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Clinical Trial NCT06153641 for Liver Transplant Rejection, Liver Transplant Failure and Rejection is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients 70 Non-Invasive Biomarker-Driven

Active, not recruiting
Clinical Trial NCT06153641 is an observational study for Liver Transplant Rejection, Liver Transplant Failure and Rejection that is active, not recruiting. It started on April 16, 2019 with plans to enroll 70 participants. Led by St. Louis University, it is expected to complete by March 31, 2026. The latest data from ClinicalTrials.gov was last updated on December 10, 2025.
Brief Summary
Liver transplantation is a lifesaving procedure; however, there are chances that the body may reject the organ following liver transplantation, and this remains a significant concern. This rejection of the transplanted, healthy liver tissue further adds to the patient's illness and also increases the related costs of treatment. Currently, liver biopsy is the standard procedure used for diagnosing this rejection. Bein...Show More
Detailed Description
Cellular rejection following liver transplantation is of worldwide occurrence and a major cause of morbidity affecting 15 to 20 percent of liver transplantation recipients. Elevation of serum aminotransferase may be suspicious of rejection and typically precedes clinical symptoms of fever and jaundice. However, such clinical signs as well biochemical parameters are neither specific nor sensitive for detection of reje...Show More
Official Title

Cytokeratin 18 a Novel Non-invasive Biomarker for Rejection in Liver Transplant Patients

Conditions
Liver Transplant RejectionLiver Transplant Failure and Rejection
Other Study IDs
  • 29508
NCT ID Number
NCT06153641
Start Date (Actual)
2019-04-16
Last Update Posted
2025-12-10
Completion Date (Estimated)
2026-03-31
Enrollment (Estimated)
70
Study Type
Observational
Status
Active, not recruiting
Keywords
Liver Transplant
Stable post liver transplant
Post transplant liver biopsy
Healthy nontransplant without liver disease
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Biopsy arm
Post-transplant patients undergoing standard of care liver biopsy (Biopsy arm).
N/A-Observational Study
N/A-Observational Study
Stable post-liver transplant arm
Stable post-liver transplantation patients without rejection (Stable post-liver transplant arm).
N/A-Observational Study
N/A-Observational Study
Healthy arm
Healthy non-transplant control patients without liver disease (Healthy arm).
N/A-Observational Study
N/A-Observational Study
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Characterize baseline CK-18 levels in healthy non transplant control patients and 'stable' post transplantation patients without rejection.
Characterize baseline CK-18 levels in healthy non transplant control patients and 'stable' post transplantation patients without rejection.
through study completion, an average of 1 year
Determine cross-sectional relationship between CK-18 levels and severity of rejection.
Determine cross-sectional relationship between CK-18 levels and severity of rejection.
through study completion, an average of 1 year
Ultimate goal would be to determine if serial CK-18 assessment could longitudinally predict rejection and its progression.
Our ultimate goal would be to determine if serial CK-18 assessment could longitudinally
through study completion, an average of 1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
1 Year
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Patients should be at least 1 year of age at enrollment.
  • There shall be no restrictions regarding sex, race or ethnicity
  • All Patients who have received a liver transplant will be approached for enrollment in the study.

Study Group-Specific Inclusion Criteria:

• The patients who are scheduled for a liver biopsy for suspicion of liver transplant rejection (Biopsy arm).

Note-1: If a patient gets a subsequent episode of rejection and the patient is scheduled for another liver biopsy after completing participation in the biopsy arm, it will make the patient eligible for re-enrollment in the study under the biopsy arm since this study captures the rejection events. The patient will be re-consented each time and given a new participant ID each time.

Note-2: If the patient gets stable in the study doctor's opinion after completing participation in the biopsy arm, it will make the patient eligible for re-enrollment in the study under the stable post-liver transplant arm. The patient will be re-consented and given a new participant ID.

Control Group specific inclusion Criteria:

• Healthy non transplant controls(Healthy arm).

Note-1: If a patient gets a liver transplant after completing participation in a healthy arm, it will make the patient eligible for re-enrollment in the study under other arms (stable post-liver transplant arm or biopsy arm). The patient will be re-consented each time and given a new participant ID each time.

• Liver transplant recipients without rejection: Patients who are 'stable' post liver transplantation would be approached (Stable post-liver transplant arm).

Note-1: If a patient gets an episode of rejection after completing participation in the stable arm, it will make the patient eligible for re-enrollment in the study under the biopsy arm since this study captures the rejection events. The patient will be re-consented each time and given a new participant ID each time.

  1. Known infectious hepatitis
  2. Patient non-compliant
  3. For patients with any unforeseen risk factors, all efforts will be made to not enroll them in the study. If a patient has exceeded the 50mL/3mL per kg limit clinically, the patient will not be enrolled in the study.
St. Louis University logoSt. Louis University
Mid-America Transplant logoMid-America Transplant
Study Responsible Party
Ajay Jain MD, Principal Investigator, Division Director of Pediatric Gastroenterology and Hepatology, St. Louis University
No contact data.
1 Study Locations in 1 Countries

Missouri

SSM Health Cardinal Glennon Children's Hospital & Saint Louis University Hospital (SSM Health- SLU Hospital), St Louis, Missouri, 63104, United States