Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03572556
• Date of registration: 08/06/2018
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire Dijon
• Public title: Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT) TangRO
• Scientific title: Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)
• Date of first enrolment: June 28, 2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03572556
• Study type: Observational

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Person who has given consent

- Adult

- Person capable of understanding spoken and written French

"Patient" group:

- Certain HHT (3 or 4 Curacao criteria - Appendix 2):

- Recurring epistaxis

- Telangiectasia of the skin or mouth

- Family hereditary context

- Arteriovenous visceral malformations

- Causal mutation identified

- Person capable of completing monthly epistaxis charts

"Control" group :

- Control subjects will be matched to patients for age (+/- 6 years) and sex.

Exclusion Criteria:

- Person not affiliated to a national health insurance scheme

- Pregnant or breastfeeding woman

- Protected adult

- Hemoglobin levels less than 9 g/dl in the last 15 days

- Progressive or recent infectious disease, autoimmune disease or cancer (less than 6
months)

- Immunosuppressive treatment in progress or recent (less than 6 months), including
systemic steroid therapy. The use of inhaled or topical steroids is not an exclusion
criterion.

- Treatment in progress or stopped less than 6 months ago or to be introduced within the
next 3 months of the following medications:

- bevacizumab

- tranexamic acid

- dipeptidyl peptidase 4 inhibitors (diabetic patient)

- beta-blockers (hypertensive patient)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hereditary Hemorrhagic Telangiectasia

Intervention(s)

Biological: Blood samples

Other: Epistaxis charts

Primary Outcome(s)

Average monthly duration (in minutes) of epistaxis over the 3 months following inclusion [Time Frame: Through study completion, an average of 3 months]

Number/mm3 of circulating TANG (CD3+CXCR4+CD31+) at inclusion. [Time Frame: At inclusion]

Secondary ID(s)

GUILHEM AMRO/AOI 2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors