Liver Disease in Adults With Alpha-1 AT Deficiency (LIDIA-A1AT)

May 23, 2019 updated by: Hospices Civils de Lyon

Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency

This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital Femme Mére Enfant - Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years old
  • Presenting an Alpha-1 AT deficiency (Alpha-1 AT level <0.8g/l at the time of diagnosis)

Exclusion Criteria:

  • Patients presenting a liver disease not related to the Alpha-1 AT deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transient elastography and fibrotest
Other: Transient Elastography and fibrotest
a Transient Elastography and an ultrasound are performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of infra clinical liver injuries
Time Frame: At least one day depending on the schedule of the exams
The prevalence of infra clinical liver injuries (lesions or liver abnormalities) in a cohort of adult patients presenting an Alpha-1 AT deficiency. Suspicion of fibrosis was defined as liver stiffness > 7.2kPa measured by transient elastography (TE).
At least one day depending on the schedule of the exams

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphological liver complications description
Time Frame: At least one day depending on the schedule of the exams
To describe all the morphological liver complications present at the moment of the investigation.
At least one day depending on the schedule of the exams
measure of biological parameters
Time Frame: At least one day depending on the schedule of the exams
- To measure the biological parameters (as AST, ALT, GGT, total bilirubin, lymphocytes, platelets, FibroTest score) and radiological aspects (TE score, liver aspect evaluated by ultrasound)
At least one day depending on the schedule of the exams

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-François MORNEX, PhD, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011.664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alpha-1 AT Deficiency

Clinical Trials on Transient Elastography and fibrotest

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe