Hereditary Bradykinetic AngioedemaMONOBRADNCT04032002
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
A study testing Explorations and Blood samples in people with Hereditary Bradykinetic Angioedema, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Bradykinetic Angioedema
- What is being tested?
- Explorations and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2020to 17 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
- 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)
Who cannot join
- 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,
Show all 25Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.
- Conditions
- Hereditary Bradykinetic Angioedema
- Being tested
- Explorations, Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExplorationsOther
On Day 1 vascular fonctions explorations performed
Blood samplesOther
On Day 1 35ml taken
| Study group | Role | What they receive |
|---|---|---|
| Patients hereditary bradykinetic angioedema | Other | Not described Receives: Other: Explorations; Other: Blood samples |
| healthy volunteers | Other | Not described Receives: Other: Explorations; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the gene expression of B1 and / or B2 monocyte receptors
compare between patients with hereditary bradykinetic angioedema and control subjects.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start10 Nov 2020
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Bradykinetic AngioedemaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032002
- Sponsor's protocol ID
- 2018/349/HP
- Acronym
- MONOBRAD
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
- ClinicalTrials.gov ID
- NCT04032002
- Acronym / sponsor ID
- MONOBRAD / 2018/349/HP
- Conditions
- Hereditary Bradykinetic Angioedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients hereditary bradykinetic angioedema | Other | Other: Explorations, Other: Blood samples |
| healthy volunteers | Other | Other: Explorations, Other: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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).
- Person affiliated with a social security scheme
Key exclusion criteria (25 listed)
- 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:
- Pregnant or parturient or breastfeeding woman or lack of proven contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExplorationsOn Day 1 vascular fonctions explorations performed | Other | Patients hereditary bradykinetic angioedema, healthy volunteers |
| Blood samplesOn Day 1 35ml taken | Other | Patients hereditary bradykinetic angioedema, healthy volunteers |
Primary outcome
compare the gene expression of B1 and / or B2 monocyte receptors
Time frame: Day 1
compare between patients with hereditary bradykinetic angioedema and control subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explorations and Blood samples in people with Hereditary Bradykinetic Angioedema, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the gene expression of B1 and / or B2 monocyte receptors (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.