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Donor Specific HLA Alloantibodies in Liver Transplantation

StatusUnknown
PhaseNot specified
Started
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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Primary completion date changed from estimate of Sep 2021 to Sep 2024v4 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1162 to confirmed 858
    • Study completion date: Sep 2021 to Dec 2024
    • Start date: Aug 2015 to Aug 15, 2015
    • Study description expanded, about 155 words
    • Site details revised at 5 of 5 sites
  3. Primary and study completion dates: Sep 2020 to Sep 2021
    • Site details revised at 4 of 5 sites
    v3
  4. Primary and study completion dates: Jun 2020 to Sep 2020
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 6 words
    • Study title shortened, about 6 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim is to evaluate the impact of donor specific HLA alloantibodies (DSA) on all-cause mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection, fibrosis, vascular, and biliary complications. Furthermore, all biopsies will be C4d stained. The hypothesizes is that donor specific HLA alloantibodies facilitate an immune mediated damage to the liver allograft that impairs function and lead to various complications. The investigators will do a prospective blinded multicenter cohort study in the Scandiatransplant organ sharing organization region. Both preformed, persistent, and de novo donor specific HLA alloantibodies will studied. Blood samples will be taken immediately prior to transplantation, and 14 days, 3 months, and 1 year after transplantation. All liver biopsies performed during the study period will be evaluated for a humoral component and blood samples will be obtained prior to liver biopsies to investigate the presence of DSA. Investigations will be fully blinded for the treatment responsible doctors.
Trial Details
NCT Number NCT02784080
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Collaborators: Sahlgrenska University Hospital, Karolinska Institutet, Helsinki University Central Hospital, Oslo University Hospital
Conditions
(from sponsor)		 Complication of Transplanted Liver
Related terms Fibrosis, Rejection, Psychology
Enrollment 858 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov