Interest of the Donor-specific Antibodies After Liver Transplantation

Liver Transplant Clinical Trial

— vaLIDLIver  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238443
• Other study ID #: 2014_18
• Secondary ID: 2015-A00418-41
• Status: Completed
• Start date: February 16, 2016
• Est. completion date: July 13, 2019

Study information

• Verified date: March 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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©)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 13, 2019
• Est. primary completion date: July 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence DSA positivity (or anti-HLA).	The positivity is defined as a fluorescence = 1000.	At baseline
Secondary	Fluorescence quantification		at 3 months, 1 year and 2 years after transplantation
Secondary	Presence of C1q binding-complement anti-HLA antibodies		at 3 months, 1 year and 2 years after transplantation