Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777435
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2021-02-19
Brief Title:
Therapeutic Orientation Test in Thrombotic Microangiopathy
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Therapeutic Orientation Test in Thrombotic Microangiopathy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOTEM
Brief Summary:
Haemolytic and Uraemic Syndrome HUS is a serious disease requiring rapid diagnosis and management The atypical HUS diagnosis has been greatly improved by anti-CS antibody Eculizumab wich block alternative complement pathway activation To rise treatment success Eculizumab introduction should be as early as possible In some secondary HUS infection drugs complement is also involved as second-hit
To date there is no tool to confirm complement involvement in a HUS at diagnosis stage This study suggest to evaluate a therapeutic orientation test in order to determine the complement implication in HUS diagnosis The test evaluates the complement deposits on endothelial cell surface in vitro compared to a normal human serum
In order to determine the test performance first the positive or negative results will be compared to the HUS clinical evolution treated or not by the clinician with Eculizumab Second the test results will be compared to the presence of alternative complement pathway regulation abnormalities
To date there is no tool to confirm complement involvement in a HUS at diagnosis stage This study suggest to evaluate a therapeutic orientation test in order to determine the complement implication in HUS diagnosis The test evaluates the complement deposits on endothelial cell surface in vitro compared to a normal human serum
In order to determine the test performance first the positive or negative results will be compared to the HUS clinical evolution treated or not by the clinician with Eculizumab Second the test results will be compared to the presence of alternative complement pathway regulation abnormalities
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None