Interest of the Donor-specific Antibodies After Liver Transplantation (vaLIDLIver)

Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant

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©)

Study Overview

• Status: Completed
• Conditions: Liver Transplant

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHRU, Hôpital Claude HURIEZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult patients transplanted at the University Hospital of Lille will be included in a prospective observational study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence DSA positivity (or anti-HLA).	The positivity is defined as a fluorescence ≥ 1000.	At baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Fluorescence quantification	at 3 months, 1 year and 2 years after transplantation
Presence of C1q binding-complement anti-HLA antibodies	at 3 months, 1 year and 2 years after transplantation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2016
• Primary Completion (ACTUAL): July 13, 2019
• Study Completion (ACTUAL): July 13, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (ACTUAL): August 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: DSA
• Other Study ID Numbers: 2014_18; 2015-A00418-41 (OTHER: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No