The Role of the Coagulation Pathways in Recurrent Angioedema | NCT02892682

Studies
The Role of the Coagulation Pathways in Recurrent Angioedema

NCT02892682

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Dec 27, 2023Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency

Interventions

BLOOD TEST

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no more inclusion

Expanded Access Info

Start Date

May 31, 2016Actual

Primary Completion Date

May 10, 2023Actual

Completion Date

May 10, 2023Actual

First Submitted Date

Sep 2, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Dec 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 AE-Bk	Other	Arm of the recurring angiodeme medié by the bradykinine: blood test	Other: BLOOD TEST
Arm 2 AE-Mast	Other	Superficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test	Other: BLOOD TEST
ARM 3 AEI	Other	Arm recurring angiodemes isolate idiopathique not hostaminergique: blood test	Other: BLOOD TEST
ARM 4 US	Other	Arm of superficial nettle rashes: blood test	Other: BLOOD TEST

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BLOOD TEST	Other		ARM 3 AEI ARM 4 US Arm 1 AE-Bk Arm 2 AE-Mast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of several coagulation pathway markers in each group		24 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

recurrent angioderma

Exclusion Criteria:

anticoagulant therapy, diseases of hemostasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montpellier University Hospital		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

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Browse Branches

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