Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor DeficiencyAngiocoagNCT02892682
The Role of the Coagulation Pathways in Recurrent Angioedema
A study testing BLOOD TEST in people with Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency
- What is being tested?
- BLOOD TEST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2016to 10 May 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recurrent angioderma
Who cannot join
- anticoagulant therapy, diseases of hemostasis
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.
Read the detailed description
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways. the main objective is to highlight a difference between the rates of different coagulation factors in the 3 groups presenting different categories of angiodemes patients with a group of patients with isolated superficial chronic urticaria
- Being tested
- BLOOD TEST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD TESTOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 AE-Bk | Other | Arm of the recurring angiodeme medié by the bradykinine: blood test Receives: Other: BLOOD TEST |
| Arm 2 AE-Mast | Other | Superficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test Receives: Other: BLOOD TEST |
| ARM 3 AEI | Other | Arm recurring angiodemes isolate idiopathique not hostaminergique: blood test Receives: Other: BLOOD TEST |
| ARM 4 US | Other | Arm of superficial nettle rashes: blood test Receives: Other: BLOOD TEST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of several coagulation pathway markers in each group
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start31 May 2016
- Primary completion10 May 2023
- Study completion10 May 2023
Why it stopped: no more inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892682
- Sponsor's protocol ID
- UF 9650
- Acronym
- Angiocoag
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2016
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Coagulation Pathways in Recurrent Angioedema
- ClinicalTrials.gov ID
- NCT02892682
- Acronym / sponsor ID
- Angiocoag / UF 9650
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more inclusion
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.
Detailed description
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways. the main objective is to highlight a difference between the rates of different coagulation factors in the 3 groups presenting different categories of angiodemes patients with a group of patients with isolated superficial chronic urticaria
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 AE-Bk | Other | Other: BLOOD TESTArm of the recurring angiodeme medié by the bradykinine: blood test |
| Arm 2 AE-Mast | Other | Other: BLOOD TESTSuperficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test |
| ARM 3 AEI | Other | Other: BLOOD TESTArm recurring angiodemes isolate idiopathique not hostaminergique: blood test |
| ARM 4 US | Other | Other: BLOOD TESTArm of superficial nettle rashes: blood test |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent angioderma
Key exclusion criteria (1 listed)
- anticoagulant therapy, diseases of hemostasis
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 |
|---|---|---|
| BLOOD TEST | Other | ARM 3 AEI, ARM 4 US, Arm 1 AE-Bk, Arm 2 AE-Mast |
Primary outcome
Levels of several coagulation pathway markers in each group
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: no more inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- 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 BLOOD TEST in people with Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency, run by University Hospital, Montpellier 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Dec 2023. 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 was stopped early (reason given: no more inclusion). Results are not available in the source record.
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?
Levels of several coagulation pathway markers in each group (time frame: 24 Months). 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 27 Dec 2023.