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Immunization Anti HLA in the Liver Transplant Recipients (DSATH) (DSATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556879
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Liver Transplantation Graft Failure Biological: Donor specific antibodies Biological: Serum bank Biological: DNA bank Procedure: Liver biopsy Procedure: Liver ultrasounds and Fibroscan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Immunization Anti HLA in the Liver Transplant Recipients (DSATH)
Actual Study Start Date : March 9, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arm Intervention/treatment
Liver retransplantation
  • 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
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)




Primary Outcome Measures :
  1. Risk of graft failure at 24 months (Odds Ratio) depending on the presence of DSA at retransplantation. [ Time Frame: 24 months after 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.


Secondary Outcome Measures :
  1. 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). [ Time Frame: retransplantation, 12 and 24 months after retransplantation ]

    The DSA will be detected by a luminex technology and the positivity will be mesurated by the mean fluorescence intensity. Histological findings of the explant associated with anti HLA immunization will be described and clustered by the approach proposed by Lefaucheur et al (34), the analysis of C4d is conducted.

    The histological abnormalities graft will be evaluated from biopsies performed at 12 and 24 months.


  2. Evaluate the association between the presence of the DSA at before retransplantation and biological abnormalities graft from the previous donor [ Time Frame: 9 months, 6 months, 3 months Before transplantation ]
  3. 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). [ Time Frame: 1, 3, 12 and 24 months after retransplantation ]
    The presence of abnormality will be determined from the AST, ALT, GGT, PAL, total and conjugated bilirubin, PT, INR.

  4. Evaluate the association between the presence of DSA and fibrosis Fibroscan measured at 12 and 24 months. (Student t-test or non parametric test). [ Time Frame: 12 and 24 months after retransplantation ]
  5. 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). [ Time Frame: 24 months after retransplantation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • HIV positive patient,
  • Multi-organ transplantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556879


Locations
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France
Unité Médicale de Transplantation Hépatique In Service d'Hépato-Gastro-Entérologie
Päris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: PERDIGAO Fabiano, PH, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02556879    
Other Study ID Numbers: P140315
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver transplantation
Graft failure
Donor specific antibodies
Additional relevant MeSH terms:
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Liver Extracts
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Hematinics