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Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation

Study acronym: iSYNAPSE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 10 to 11
  2. Interventions modified Eligibility criteria expanded, about 13 words · Secondary endpoints: 4 to 3 · Site details revised at 8 of 10 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 4 to 3
    • Site details revised at 8 of 10 sites
  3. Recruitment opened Start date changed from estimate of May 8, 2026 to May 14, 2026 · Study sites revised (10)v2 Show 2 more changesShow less
    • Start date changed from estimate of May 8, 2026 to May 14, 2026
    • Study sites revised (10)

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months. The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)
Trial Details
NCT Number NCT07549503
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Liver Transplant
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov