Interest of the Donor-specific Antibodies After Liver Transplantation

NCT ID: NCT03238443

Last Updated: 2021-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-16

Study Completion Date

2019-07-13

Brief Summary

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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©)

Detailed Description

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Conditions

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Liver Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Dharancy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00418-41

Identifier Type: OTHER

Identifier Source: secondary_id

2014_18

Identifier Type: -

Identifier Source: org_study_id

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