NCT03942315

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

7.1 years

First QC Date

May 2, 2019

Last Update Submit

May 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence)

    Recurrent clinical examinations (including laboratory, histological and radiological investigations)

    Every 6 months after transplantation up to 5 years

Study Arms (1)

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

Interventions

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.

Liver transplant in Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant

You may qualify if:

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

You may not qualify if:

  • Patient who died in the year following transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jérôme DUMORTIER, MD

    Hospices Civils de Lyon (Hôpital Edouard Herriot )

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 8, 2019

Study Start

January 1, 2011

Primary Completion

February 1, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2019

Record last verified: 2019-05