Immunization Anti HLA in the Liver Transplant Recipients (DSATH)

NCT02556879 | Unknown

• 1 other identifier: P140315
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver transplantation; Graft failure; Donor specific antibodies

Outcome Measures

Primary Outcomes (1)

• Risk of graft failure at 24 months (Odds Ratio) depending on the presence of DSA at retransplantation.

  The graft failure is defined by abnormal hepatic tests (AST, ALT, GGT, PAL, total and conjugated bilirubin, PT, INR), and/or abnormal hepatic histology , and/or abnormal hepatic imagery.

  24 months after retransplantation

Secondary Outcomes (5)

• Evaluate the association between the presence of the DSA at retransplantation and histological abnormalities of the explant and graft. ( Pearson's chi-square test or Fischer exact test).

  retransplantation, 12 and 24 months after retransplantation

• Evaluate the association between the presence of the DSA at before retransplantation and biological abnormalities graft from the previous donor

  9 months, 6 months, 3 months Before transplantation

• Evaluate the association between the presence of the DSA at retransplantation and biological abnormalities graft at 1, 3, 12 and 24 months.( Pearson's chi-square test or Fischer exact test).

  1, 3, 12 and 24 months after retransplantation

• Evaluate the association between the presence of DSA and fibrosis Fibroscan measured at 12 and 24 months. (Student t-test or non parametric test).

  12 and 24 months after retransplantation

• Evaluate the association between the number of acute rejection episodes and the presence of the DSA at retransplantation and their evolution (especially of recurrence).(Pearson's chi-square test or Fischer exact test).

  24 months after retransplantation

Study Arms (1)

Liver retransplantation

OTHER

* Donor specific antibodies :Additional samples for Donor specific at each visit * Serum bank : Additional samples for serum bank at each visit if possible * DNA banq : Additional sample for DNA banq at inclusion visit if possible * Liver biopsy :Liver biopsy at 12 and 24 months after retransplantation (dependind the centers : procedure performed in routine or interventional procedure) * Liver ultrasounds and Fibroscan : Liver ultrasounds and Fibroscan at 12 and 24 months after retransplantation (dependind the centers : procedure performed in routine or interventional procedure)

Biological: Donor specific antibodies; Biological: Serum bank; Biological: DNA bank; Procedure: Liver biopsy; Procedure: Liver ultrasounds and Fibroscan

Interventions

Donor specific antibodies BIOLOGICAL

Additional samples for Donor specific antibodies at each visit

Liver retransplantation

Serum bank BIOLOGICAL

Additional samples for serum bank at each visit if possible

Liver retransplantation

DNA bank BIOLOGICAL

Additional sample for DNA bank at inclusion visit if possible

Liver retransplantation

Liver biopsy PROCEDURE

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

Liver retransplantation

Liver ultrasounds and Fibroscan PROCEDURE

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

Liver retransplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years with no upper age limit,
• Candidate for a liver retransplantation, whatever the indication, the period or the number of retransplantation
• Recipient of a social protection scheme or entitled
• Signature of informed consent

You may not qualify if:

• HIV positive patient,
• Multi-organ transplantation.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Unité Médicale de Transplantation Hépatique In Service d'Hépato-Gastro-Entérologie

Päris, 75013, France

Location

MeSH Terms

Interventions

Gene Library

Intervention Hierarchy (Ancestors)

Genetic Structures; Genetic Phenomena

Study Officials

• PERDIGAO Fabiano, PH, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: September 22, 2015
• Study Start: March 9, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

FR (1)