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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05383573
Other study ID # 8217
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source University Hospital, Strasbourg, France
Contact Ariane ZALOSZYC, MD
Phone 33 3 88 12 77 49
Email ariane.zaloszyc@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The incidence in pediatrics is very low (about 0.5 per million according to a French study) and therefore the data on the pathology very poor, especially on the therapeutic level. Without appropriate treatment, the mortality rate of the pathology is very high. Existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments. Complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. The purpose of the study is to achieve a national comparison of clinical and therapeutic practices.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion criteria: - Minor subject (<18 years old) - Diagnosis of ANCA vasculitis according to the international criteria for defining the pathology, GPA or MPA form between 2011 and 2020. - Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. Exclusion criteria: - Subject (or his parents) having expressed his (their) opposition to participating in the study - Patients with vasculitis has ANCA in the form of EGPA - Associated pathologies that cannot be related to the diagnosis of ANCA vasculitis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retrospective study of clinical and therapeutic practices at the national level. Files analysed retrospectively from January 01, 2011 to December 31, 2020 will be examined]
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