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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
History of Changes
  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:

MedlinePlus related topics: Hospice Care
U.S. FDA Resources

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
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 May 16, 2013