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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01455298
First received: October 17, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Alpha-1 AT Deficiency
Other: Transient Elastography and fibrotest

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • The prevalence of infra clinical liver injuries [ Time Frame: At least one day depending on the schedule of the exams ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • morphological liver complications description [ Time Frame: At least one day depending on the schedule of the exams ] [ Designated as safety issue: No ]
    To describe all the morphological liver complications present at the moment of the investigation.

  • measure of biological parameters [ Time Frame: At least one day depending on the schedule of the exams ] [ Designated as safety issue: No ]
    - 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)


Enrollment: 33
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transient elastography and fibrotest Other: Transient Elastography and fibrotest
a Transient Elastography and an ultrasound are performed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455298

Locations
France
Hôpital Femme Mère Enfant - Hospices Civils de Lyon
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-François MORNEX, PhD, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01455298     History of Changes
Other Study ID Numbers: 2011.664
Study First Received: October 17, 2011
Last Updated: October 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Alpha-1 AT deficiency
liver injury
Transient Elastography
FibroTest

Additional relevant MeSH terms:
Alpha 1-Antitrypsin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014