Hereditary Haemorrhagic TelangiectasiaHHTNCT03942315
Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation
An observational study of Hereditary Haemorrhagic Telangiectasia and Liver Transplant, run by Hospices Civils de Lyon.
Trial summary
Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hereditary Haemorrhagic Telangiectasia, Liver Transplant
- What is being tested?
- Data collection from standard follow-up after liver transplant
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant
Who may be able to join
- Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT
Who cannot join
- Patient who died in the year following transplantation
About this study
Official title: Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights.
Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.
- Being tested
- Data collection from standard follow-up after liver transplant
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from standard follow-up after liver transplantOther
All patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant in Hereditary Hemorrhagic Telangiectasia | Hereditary Hemorrhagic Telangiectasia (HHT) patients who underwent a liver transplant in Lyon between 1993 and 2010, and who survived more than 1 year after transplantation. Receives: Other: Data collection from standard follow-up after liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence)
Recurrent clinical examinations (including laboratory, histological and radiological investigations)
Measured: Every 6 months after transplantation up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Jan 2011
- Primary completion1 Feb 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Haemorrhagic TelangiectasiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme DUMORTIER, MD, Principal investigator, Hospices Civils de Lyon (Hôpital Edouard Herriot )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942315
- Sponsor's protocol ID
- HHT
- Acronym
- HHT
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights.
- ClinicalTrials.gov ID
- NCT03942315
- Acronym / sponsor ID
- HHT / HHT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 8 May 2019 (actual)
- 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.
Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant in Hereditary Hemorrhagic Telangiectasia | – | Other: Data collection from standard follow-up after liver transplantHereditary Hemorrhagic Telangiectasia (HHT) patients who underwent a liver transplant in Lyon between 1993 and 2010, and who survived more than 1 year after transplantation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant
Key inclusion criteria (1 listed)
- Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT
Key exclusion criteria (1 listed)
- Patient who died in the year following transplantation
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 |
|---|---|---|
| Data collection from standard follow-up after liver transplantAll patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure. | Other | Liver transplant in Hereditary Hemorrhagic Telangiectasia |
Primary outcome
Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence)
Time frame: Every 6 months after transplantation up to 5 years
Recurrent clinical examinations (including laboratory, histological and radiological investigations)
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 8 May 2019.
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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.
Jérôme DUMORTIER, MD principal investigator
Hospices Civils de Lyon (Hôpital Edouard Herriot )
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Haemorrhagic Telangiectasia and Liver Transplant, run by Hospices Civils de Lyon.
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 1 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 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence) (time frame: Every 6 months after transplantation up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2019.