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OpenTrials
Completed

NCT Number: NCT01455298

Liver Disease in Adults 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.

Completed

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Key information

Conditions

Alpha-1 AT Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme Mère Enfant - Hospices Civils de Lyon

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transient Elastography and fibrotest

Other

a Transient Elastography and an ultrasound are performed.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: LIDIA-A1AT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.