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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation

Clinicaltrials.gov identifier NCT03942315

Recruitment Status Completed

First Posted May 8, 2019

Last update posted May 8, 2019

Study Description

Brief 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. 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.

  • Condition or Disease:Hereditary Haemorrhagic Telangiectasia
    Liver Transplant
  • Intervention/Treatment: Other: Data collection from standard follow-up after liver transplant
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 14 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights.
  • Actual Study Start Date: January 2011
  • Actual Primary Completion Date: February 2018
  • Actual Study Completion Date: December 2018
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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.
Other: Data collection from standard follow-up after liver transplant
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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)
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant
Criteria

Inclusion Criteria:

- Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for
HHT

Exclusion Criteria:

- Patient who died in the year following transplantation

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Jérôme DUMORTIER, MD Hospices Civils de Lyon (Hôpital Edouard Herriot )

More Information
  • Responsible Party: Hospices Civils de Lyon
  • ClinicalTrials.gov Identifier: NCT03942315 History of Changes
  • Other Study ID Numbers: HHT
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: May 8, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Telangiectasis
    Telangiectasia, Hereditary Hemorrhagic
    Recurrence