Interest of the Donor-specific Antibodies After Liver Tra... | NCT03238443

Studies
Interest of the Donor-specific Antibodies After Liver Transplantation

NCT03238443

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Mar 25, 2021Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Liver Transplant

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-A00418-41	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2016Actual

Primary Completion Date

Jul 13, 2019Actual

Completion Date

Jul 13, 2019Actual

First Submitted Date

Jul 31, 2017

First Submission Date that Met QC Criteria

Jul 31, 2017

First Posted Date

Aug 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2021

Last Update Posted Date

Mar 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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©)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence DSA positivity (or anti-HLA).	The positivity is defined as a fluorescence ≥ 1000.	At baseline

Secondary Outcomes

Measure	Description	Time Frame
Fluorescence quantification		at 3 months, 1 year and 2 years after transplantation
Presence of C1q binding-complement anti-HLA antibodies		at 3 months, 1 year and 2 years after transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All consecutive adult patients transplanted at the University Hospital of Lille will be included in a prospective observational study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sébastien Dharancy, MD, PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU, Hôpital Claude Huriez		Lille			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided