Liver TransplantvaLIDLIverNCT03238443
Interest of the Donor-specific Antibodies After Liver Transplantation
An observational study of Liver Transplant, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2016to 13 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients transplanted at the University Hospital of Lille will be included in a prospective observational study.
Who may be able to join
- 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
Who cannot join
- Minor patients.
- Pregnant women or during lactation.
- Patient under curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant
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©)
- Conditions
- Liver Transplant
- Keywords
- DSA
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence DSA positivity (or anti-HLA).
The positivity is defined as a fluorescence ≥ 1000.
Measured: At baseline
Secondary outcomes (2)
Fluorescence quantification
Measured: at 3 months, 1 year and 2 years after transplantation
Presence of C1q binding-complement anti-HLA antibodies
Measured: at 3 months, 1 year and 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start16 Feb 2016
- Primary completion13 Jul 2019
- Study completion13 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Dharancy, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238443
- Sponsor's protocol ID
- 2014_18
- Other IDs
- 2015-A00418-41
- Acronym
- vaLIDLIver
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant
- ClinicalTrials.gov ID
- NCT03238443
- Acronym / sponsor ID
- vaLIDLIver / 2014_18
- Conditions
- Liver Transplant
- Keywords
- DSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 13 Jul 2019 (actual)
- Study completion
- 13 Jul 2019 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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©)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients transplanted at the University Hospital of Lille will be included in a prospective observational study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Minor patients.
- Pregnant women or during lactation.
- Patient under curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence DSA positivity (or anti-HLA).
Time frame: At baseline
The positivity is defined as a fluorescence ≥ 1000.
2 secondary outcomes
Fluorescence quantification
Time frame: at 3 months, 1 year and 2 years after transplantation
Presence of C1q binding-complement anti-HLA antibodies
Time frame: at 3 months, 1 year and 2 years after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Dharancy, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence DSA positivity (or anti-HLA). (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.