ANGIOEDEMACloudRHAENCT03845946
CLOUD-R HAE REGISTRY
An observational study of ANGIOEDEMA, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ANGIOEDEMA
- What is being tested?
- angioedema
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Sep 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient with isolated angioedema without associated wheals
Who may be able to join
- Any patient with isolated angioedema without associated wheals.
- Patients with hereditary angioedema with or without C1 deficiency.
- Major patient with consent (signature)
- Minor patient whose parents / legal guardians have given their consent (signature)
Who cannot join
- Patient unable to give consent.
- Wheals with angioedema
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, Isere, 38043
Laurence Bouillet, MD, PhD, +33476765565, lbouillet@chu-grenoble.fr
About this study
Official title: International Registry of Isolated Angioedema
Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.
Read the detailed description
The Grenoble center is the registry coordinator at the national level. It will contract directly with the Cloud R Company and will be in charge of coordinating the associated centers. It will therefore send the necessary documents for the good execution of the study, will ask each center to respect the current French regulatory, will organize and finance the set-up of the register in the associated centers.
The coordinating center will also centralize requests for data, publications or creation of additional eCRF pages of associated centers. It will be able to organize a national scientific committee every 6 months. It will thus be the link between the French centers, the scientific committee of the registry and the company Cloud R.
The coordinating center will also be responsible for enter and reliability of patient data from it center, as well as the associated centers.
Role of associated centers Associated Centers will be responsible for capturing and data reliability of their patients in eCRF, they will also create a personal account for each patient so that it can download the application "cloud R HAE carnet de suivi".
Investigators referent patient will have validated at each visit or after contact with the patient crisis returned to the patient via it electronic diary.
Associated Centers will keep informed twice a year the coordinator center of the state of inclusions in the register.
- Conditions
- ANGIOEDEMA
- Being tested
- angioedema
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioedemaBehavioural
electronic tracking book
| Study group | Role | What they receive |
|---|---|---|
| Hereditary angioedema type I/II | Hereditary angioedema with C1Inh deficiency Receives: Behavioral: angioedema | |
| Acquired angioedema | Angioedema with acquired C1Inh deficiency Receives: Behavioral: angioedema | |
| Drug induced angioedema | Angioedema associated with ACEi used Receives: Behavioral: angioedema | |
| Mast cell induced angioedema | Spontaneous mast cell induced isolated angioedema Receives: Behavioral: angioedema | |
| Hereditary angioedema with nC1Inh | Hereditary angioedema with normal C1Inh and with F12, PLG, ANGPT2 mutations Receives: Behavioral: angioedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic patient data
Sexe and age of patient
Measured: 5 years
Clinical characteristics
summary of patient visit report
Measured: 5 years
Comorbidity
additional diseases
Measured: 5 years
Angioedema diagnosis
type of angiodema
Measured: 5 years
Angioedema diagnosis
position of genetic mutation if applicable
Measured: 5 years
Angioedema diagnosis
biology marker : C1inh, C4, C1q, anti C1inh
Measured: 5 years
Angioedema diagnosis
family history
Measured: 5 years
Duration and severity of acute angioedema events
start date
Measured: 5 years
Duration and severity of acute angioedema events
localization
Measured: 5 years
Duration and severity of acute angioedema events
time before treatment
Measured: 5 years
Duration and severity of acute angioedema events
time to resolution
Measured: 5 years
Duration and severity of acute angioedema events
need access to hospital
Measured: 5 years
Treatments used in managing the acute angioedema event
name
Measured: 5 years
Treatments used in managing the acute angioedema event
dose
Measured: 5 years
Treatments used in managing the acute angioedema event
date and time of acute treatment
Measured: 5 years
Treatments used in the prophylaxis of angioedema
name
Measured: 5 years
Treatments used in the prophylaxis of angioedema
dose
Measured: 5 years
Treatments used in the prophylaxis of angioedema
start date
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANGIOEDEMAStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- laurence bouillet, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845946
- Sponsor's protocol ID
- 38RC17.187
- Acronym
- CloudRHAE
- Status last verified
- Oct 2021
- First submitted
- 8 Jan 2019
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry of Isolated Angioedema
- ClinicalTrials.gov ID
- NCT03845946
- Acronym / sponsor ID
- CloudRHAE / 38RC17.187
- Conditions
- ANGIOEDEMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 19 Feb 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.
Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.
Detailed description
The Grenoble center is the registry coordinator at the national level. It will contract directly with the Cloud R Company and will be in charge of coordinating the associated centers. It will therefore send the necessary documents for the good execution of the study, will ask each center to respect the current French regulatory, will organize and finance the set-up of the register in the associated centers.
The coordinating center will also centralize requests for data, publications or creation of additional eCRF pages of associated centers. It will be able to organize a national scientific committee every 6 months. It will thus be the link between the French centers, the scientific committee of the registry and the company Cloud R.
The coordinating center will also be responsible for enter and reliability of patient data from it center, as well as the associated centers.
Role of associated centers Associated Centers will be responsible for capturing and data reliability of their patients in eCRF, they will also create a personal account for each patient so that it can download the application "cloud R HAE carnet de suivi".
Investigators referent patient will have validated at each visit or after contact with the patient crisis returned to the patient via it electronic diary.
Associated Centers will keep informed twice a year the coordinator center of the state of inclusions in the register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hereditary angioedema type I/II | – | Behavioral: angioedemaHereditary angioedema with C1Inh deficiency |
| Acquired angioedema | – | Behavioral: angioedemaAngioedema with acquired C1Inh deficiency |
| Drug induced angioedema | – | Behavioral: angioedemaAngioedema associated with ACEi used |
| Mast cell induced angioedema | – | Behavioral: angioedemaSpontaneous mast cell induced isolated angioedema |
| Hereditary angioedema with nC1Inh | – | Behavioral: angioedemaHereditary angioedema with normal C1Inh and with F12, PLG, ANGPT2 mutations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with isolated angioedema without associated wheals
Key inclusion criteria (4 listed)
- Any patient with isolated angioedema without associated wheals.
- Patients with hereditary angioedema with or without C1 deficiency.
- Major patient with consent (signature)
- Minor patient whose parents / legal guardians have given their consent (signature)
Key exclusion criteria (2 listed)
- Patient unable to give consent.
- Wheals with angioedema
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 |
|---|---|---|
| angioedemaelectronic tracking book | Behavioural | Acquired angioedema, Drug induced angioedema, Hereditary angioedema type I/II, Hereditary angioedema with nC1Inh, Mast cell induced angioedema |
Primary outcome
Demographic patient data
Time frame: 5 years
Sexe and age of patient
Clinical characteristics
Time frame: 5 years
summary of patient visit report
Comorbidity
Time frame: 5 years
additional diseases
Angioedema diagnosis
Time frame: 5 years
type of angiodema
Angioedema diagnosis
Time frame: 5 years
position of genetic mutation if applicable
Angioedema diagnosis
Time frame: 5 years
biology marker : C1inh, C4, C1q, anti C1inh
Angioedema diagnosis
Time frame: 5 years
family history
Duration and severity of acute angioedema events
Time frame: 5 years
start date
Duration and severity of acute angioedema events
Time frame: 5 years
localization
Duration and severity of acute angioedema events
Time frame: 5 years
time before treatment
Duration and severity of acute angioedema events
Time frame: 5 years
time to resolution
Duration and severity of acute angioedema events
Time frame: 5 years
need access to hospital
Treatments used in managing the acute angioedema event
Time frame: 5 years
name
Treatments used in managing the acute angioedema event
Time frame: 5 years
dose
Treatments used in managing the acute angioedema event
Time frame: 5 years
date and time of acute treatment
Treatments used in the prophylaxis of angioedema
Time frame: 5 years
name
Treatments used in the prophylaxis of angioedema
Time frame: 5 years
dose
Treatments used in the prophylaxis of angioedema
Time frame: 5 years
start date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for ANGIOEDEMA
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
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Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
Active, not recruitingPhase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Hereditary Angioedema
Enrolling by invitationPhase 3
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Hereditary Angioedema (HAE)
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.
laurence bouillet principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANGIOEDEMA, run by University Hospital, Grenoble 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Nov 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact laurence bouilelt, MD, PhD (+33476765565, lbouillet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic patient data (time frame: 5 years). The study lists 18 primary outcomes in all. 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 1 Nov 2021.