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Immunization Anti HLA in the Liver Transplant Recipients (DSATH)

NCT02556879 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-02

No results posted yet for this study

Summary

Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to dysfunction and graft loss , especially among candidates for retransplantation, that have major immunization.

This study will analyzed immunization markers at the time of liver retransplantation and systematically in patients follow-up. This will allow to characterize the histological lesions due to humoral immunization, to establish further investigations and to adapt early immunosuppressive therapy.

Conditions

  • Liver Transplantation
  • Graft Failure

Interventions

BIOLOGICAL

Donor specific antibodies

Additional samples for Donor specific antibodies at each visit

BIOLOGICAL

Serum bank

Additional samples for serum bank at each visit if possible

BIOLOGICAL

DNA bank

Additional sample for DNA bank at inclusion visit if possible

PROCEDURE

Liver biopsy

Liver biopsy at 12 and 24 months after retransplantation (depending the centers : procedure performed in routine or interventional procedure)

PROCEDURE

Liver ultrasounds and Fibroscan

Liver ultrasounds and Fibroscan at 12 and 24 months after retransplantation (depending the centers : procedure performed in routine or interventional procedure)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • PERDIGAO Fabiano, PH, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-09
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556879 on ClinicalTrials.gov