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vaLIDLIver: Interest of the Donor-specific Antibodies After Liver Transplantation

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT03238443
Collaborator
(none)
120
Enrollment
1
Location
40.8
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is a prospective observational mono center study

Primary objective :

Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation.

Secondary objective :

  • Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)

  • Impact of DSA on:

  • Graft and patients survivals

  • Onset of allograft rejection (acute, late-onset, chronic)

  • Unexplained liver graft dysfunction

  • Unexplained liver enzymes abnormalities

  • Liver fibrosis development (liver stiffness study using fibroscan©)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant
    Actual Study Start Date :
    Feb 16, 2016
    Actual Primary Completion Date :
    Jul 13, 2019
    Actual Study Completion Date :
    Jul 13, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence DSA positivity (or anti-HLA). [At baseline]

      The positivity is defined as a fluorescence ≥ 1000.

    Secondary Outcome Measures

    1. Fluorescence quantification [at 3 months, 1 year and 2 years after transplantation]

    2. Presence of C1q binding-complement anti-HLA antibodies [at 3 months, 1 year and 2 years after transplantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Liver transplanted patients older than 18, transplanted in Lille University Hospital.

    • Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy).

    • Patients with health insurance

    Exclusion Criteria:

    • Minor patients.

    • Pregnant women or during lactation.

    • Patient under curatorship.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU, Hôpital Claude Huriez Lille France

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Sébastien Dharancy, MD, PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT03238443
    Other Study ID Numbers:
    • 2014_18
    • 2015-A00418-41
    First Posted:
    Aug 3, 2017
    Last Update Posted:
    Mar 25, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    DSA

    Study Results

    No Results Posted as of Mar 25, 2021