Liver Disease in Adults With Alpha-1 AT Deficiency

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455298

Acronym

LIDIA-A1AT

Enrollment

Registered

2011-10-19

Start date

2011-05-31

Completion date

2012-03-31

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha-1 AT Deficiency

Keywords

Alpha-1 AT deficiency, liver injury, Transient Elastography, FibroTest

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.

Interventions

OTHERTransient Elastography and fibrotest

a Transient Elastography and an ultrasound are performed.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026