Liver Disease in Adults With Alpha-1 AT Deficiency

Not Applicable

Completed

• Conditions: Alpha-1 AT Deficiency
• Interventions: Other: Transient Elastography and fibrotest

• Registration Number: NCT01455298
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-19
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-10
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transient elastography and fibrotest	Transient Elastography and fibrotest	-

Primary Outcome Measures

Name	Time	Method
The prevalence of infra clinical liver injuries	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).

Secondary Outcome Measures

Name	Time	Method
morphological liver complications description	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.
measure of biological parameters	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)

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant - Hospices Civils de Lyon; 🇫🇷 Bron, France