Alpha-1 AT DeficiencyLIDIA-A1ATNCT01455298
Liver Disease in Adults With Alpha-1 AT Deficiency
A study testing Transient Elastography and fibrotest in people with Alpha-1 AT Deficiency, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alpha-1 AT Deficiency
- What is being tested?
- Transient Elastography and fibrotest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- Presenting an Alpha-1 AT deficiency (Alpha-1 AT level <0.8g/l at the time of diagnosis)
Who cannot join
- Patients presenting a liver disease not related to the Alpha-1 AT deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research of Infra Clinical Liver Injuries in Adult Patients Presented 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.
- Conditions
- Alpha-1 AT Deficiency
- Being tested
- Transient Elastography and fibrotest
- Keywords
- Alpha-1 AT deficiency, liver injury, Transient Elastography, FibroTest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient Elastography and fibrotestOther
a Transient Elastography and an ultrasound are performed.
| Study group | Role | What they receive |
|---|---|---|
| Transient elastography and fibrotest | Other | Not described Receives: Other: Transient Elastography and fibrotest |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of infra clinical liver injuries
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).
Measured: At least one day depending on the schedule of the exams
Secondary outcomes (2)
morphological liver complications description
To describe all the morphological liver complications present at the moment of the investigation.
Measured: At least one day depending on the schedule of the exams
measure of biological parameters
- 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)
Measured: At least one day depending on the schedule of the exams
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alpha-1 AT DeficiencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François MORNEX, PhD, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455298
- Sponsor's protocol ID
- 2011.664
- Acronym
- LIDIA-A1AT
- Status last verified
- Oct 2012
- First submitted
- 17 Oct 2011
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Guillaud O, Dumortier J, Traclet J, Restier L, Joly P, Chapuis-Cellier C, Lachaux A, Mornex JF. Assessment of liver fibrosis by transient elastography (Fibroscan(R)) in patients with A1AT deficiency. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):77-81. doi: 10.1016/j.clinre.2018.08.016. Epub 2019 Jan 3.
PubMed 30612958
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency
- ClinicalTrials.gov ID
- NCT01455298
- Acronym / sponsor ID
- LIDIA-A1AT / 2011.664
- Conditions
- Alpha-1 AT Deficiency
- Keywords
- Alpha-1 AT deficiency, liver injury, Transient Elastography, FibroTest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transient elastography and fibrotest | Other | Other: Transient Elastography and fibrotest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Presenting an Alpha-1 AT deficiency (Alpha-1 AT level <0.8g/l at the time of diagnosis)
Key exclusion criteria (1 listed)
- Patients presenting a liver disease not related to the Alpha-1 AT deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient Elastography and fibrotesta Transient Elastography and an ultrasound are performed. | Other | Transient elastography and fibrotest |
Primary outcome
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).
2 secondary outcomes
morphological liver complications description
Time frame: At least one day depending on the schedule of the exams
measure of biological parameters
Time frame: At least one day depending on the schedule of the exams
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 30612958Guillaud O, Dumortier J, Traclet J, Restier L, Joly P, Chapuis-Cellier C, Lachaux A, Mornex JF. Assessment of liver fibrosis by transient elastography (Fibroscan(R)) in patients with A1AT deficiency. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):77-81. doi: 10.1016/j.clinre.2018.08.016. Epub 2019 Jan 3.
Related trials for Alpha-1 AT Deficiency
Enrolling by invitationObservational study
AATD-Liver Scan Study
Alpha-1 Antitrypsin Deficiency, AATD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François MORNEX, PhD, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transient Elastography and fibrotest in people with Alpha-1 AT Deficiency, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of infra clinical liver injuries (time frame: At least one day depending on the schedule of the exams). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01455298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.