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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04032002
Other study ID # 2018/349/HP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2019
Est. completion date September 2021

Study information

Verified date July 2019
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria (patients):

- Patient with inherited bradykinic angioedema due to quantitative or qualitative C1-inhibitor deficiencies, regardless of the frequency or severity of seizures and regardless of their background treatment, with the following diagnostic criteria:

- C1-inhibitor rate <50% of normal

- Repeated episodes characteristic of bradykinic angioedema

- Hereditary nature of the disease.

- Person who read and understood the newsletter and signed the consent form

- Person affiliated with a social security scheme

- Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmatory diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).

Inclusion Criteria (volunteers):

- Person affiliated with a social security scheme

- Person who read and understood the newsletter and signed the consent form

- Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit)

Exclusion Criteria (patients):

- Angioedema crisis less than 1 month old

- Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.

- Acute infection in progress, with or without anti-infectious treatment

- Contraindication to the use of trinitrin:

- Hypersensitivity to nitrates or to any of the excipients

- shock, severe hypotension,

- obstructive cardiomyopathy,

- inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,

- intracranial hypertension,

- patient treated with sildenafil

- Pregnant or parturient or breastfeeding woman or lack of proven contraception

- Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship

- Patient participating or having participated in another therapeutic trial within one week.

Exclusion Criteria (volunteers)

- Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.

- Acute infection in progress, with or without anti-infectious treatment

- Contraindication to the use of trinitrin:

- Hypersensitivity to nitrates or to any of the excipients

- shock, severe hypotension,

- obstructive cardiomyopathy,

- inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,

- intracranial hypertension,

- patient treated with sildenafil

- Pregnant or parturient or breastfeeding woman or lack of proven contraception

- Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship

- Person participating or having participated in another therapeutic trial within one week.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Explorations
On Day 1 vascular fonctions explorations performed
Blood samples
On Day 1 35ml taken

Locations

Country Name City State
France DRCI Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary compare the gene expression of B1 and / or B2 monocyte receptors compare between patients with hereditary bradykinetic angioedema and control subjects. Day 1