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OpenTrials
Completed

NCT Number: NCT03238443

Interest of the Donor-specific Antibodies After Liver Transplantation

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©)

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Key information

Conditions

Liver Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence DSA positivity (or anti-HLA).

    Time frame: At baseline

    The positivity is defined as a fluorescence ≥ 1000.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant

Acronym: vaLIDLIver

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2017
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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