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

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Jul 1, 2025 to Jan 13, 2025
    • Study completion date: Sep 24, 2025 to Mar 31, 2026
    v6
  2. Notable Primary completion date: Sep 24, 2024 to Jul 1, 2025
    • Study completion date: Sep 24, 2024 to Sep 24, 2025
    v5
  3. Minor Primary completion date: Aug 24, 2024 to Sep 24, 2024v4
  4. Minor Primary completion date: Jul 15, 2024 to Aug 24, 2024v3
  5. Notable Primary completion date: Jan 15, 2024 to Jul 15, 2024v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Being an invasive procedure (requiring the introduction of instruments into the body), this procedure also increases the chances of death of the patient. Researchers are looking into the identification of testing methods that can act as a sign of this rejection without requiring the introduction of instruments into the body. This type of testing could also allow for adjusting the doses of drugs given to the patient to decrease the chances of graft failure. A particular event that occurs during rejection in the body is the death of liver cells. Thus, tracking cell death using a blood test would be an important tool in assessing rejection. CK-18 is a protein in the liver cells that is thought to be linked to the changes occurring as a result of cell death. This study will be looking into a new idea of measuring CK-18 levels and compare them to an existing index to develop a reliable test for liver transplant rejection without introducing any instruments into the body. The purpose of this research study is to assess the history and collect blood samples to be tested for measuring CK-18 levels and assess certain other markers in the blood.
Trial Details
NCT Number NCT06153641
Lead Sponsor St. Louis University
Collaborators: Mid-America Transplant
Conditions
(from sponsor)
Liver Transplant Rejection, Liver Transplant Failure and Rejection
Related terms Rejection, Psychology
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov