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CompletedNCT04302246SEPTIFOIEUpdated Mar 10, 2020

Immune Function Following Liver Transplantation

An observational study in Liver Transplant; Complications, sponsored by Assistance Publique - Hôpitaux de Paris. Completed. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
1 Day to 18 Years
Sex
All
01

Study summary

Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.

Read the detailed description

Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.

02

Conditions studied

  • Liver Transplant; Complications
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Child admitted for liver transplantation

Inclusion criteria

  • Child under 18 admitted for liver transplantation
  • Signature of consent by the two holders of parental authority.
  • Informing children as far as their age and condition allow.
  • Affiliation to a social protection

Exclusion criteria

Exclusion Criteria:

  • Children under 6 kg
  • Children transplanted for primary graft dysfunction
  • Children scheduled for liver-kidney transplants
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • GeneticBiological testing on sequential blood sample

    Biological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs.

06

What researchers measure

Primary outcomes

  1. Immune functionnal profile

    quantitative monocytes mHLA-DR measurment

    Time frame: pre-operatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04302246
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 10, 2020
Start date
Jan 8, 2016
Primary completion
Dec 17, 2019
Completion
Dec 17, 2019
Last update
Mar 10, 2020

Study contacts

Pierre TISSIERES
principal investigator · Assistance Publique des Hopitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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