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Trial record 21 of 883 for:    Liver Transplant

Interest of the Donor-specific Antibodies After Liver Transplantation (vaLIDLIver)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03238443
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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©)

Condition or disease
Liver Transplant

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant
Actual Study Start Date : February 16, 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence DSA positivity (or anti-HLA). [ Time Frame: At baseline ]
    The positivity is defined as a fluorescence ≥ 1000.


Secondary Outcome Measures :
  1. Fluorescence quantification [ Time Frame: at 3 months, 1 year and 2 years after transplantation ]
  2. Presence of C1q binding-complement anti-HLA antibodies [ Time Frame: at 3 months, 1 year and 2 years after transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive adult patients transplanted at the University Hospital of Lille will be included in a prospective observational study.
Criteria

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.

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): NCT03238443


Contacts
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Contact: Sébastien Dharancy, MD,PhD 3 20 44 53 21 ext +33 sebastien.dharancy@chru-lille.fr

Locations
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France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Sébastien Dharancy, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Sébastien Dharancy, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03238443     History of Changes
Other Study ID Numbers: 2014_18
2015-A00418-41 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
DSA

Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs