NCT03238443

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©)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2019

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

3.4 years

First QC Date

July 31, 2017

Last Update Submit

March 24, 2021

Conditions

Liver Transplant

Keywords

DSA

Outcome Measures

Primary Outcomes (1)

  • Prevalence DSA positivity (or anti-HLA).

    The positivity is defined as a fluorescence ≥ 1000.

    At baseline

Secondary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Minor patients.
  • Pregnant women or during lactation.
  • Patient under curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Study Officials

  • Sébastien Dharancy, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 3, 2017

Study Start

February 16, 2016

Primary Completion

July 13, 2019

Study Completion

July 13, 2019

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)