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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03942315
Other study ID # HHT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date December 1, 2018

Study information

Verified date May 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patient who died in the year following transplantation

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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