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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05702996
Other study ID # 2020/0206/HP
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date March 2023
Est. completion date September 2025

Study information

Verified date January 2023
Source University Hospital, Rouen
Contact Steven GRANGE, MD
Phone +3323288
Email steven.grange@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eculizumab administration
Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab

Locations

Country Name City State
France Amiens University Hospital Amiens
France Rouen University Hospital Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from initiation of eculizumab treatment to renal remission maximum 12 months
Secondary Number of AE and SAE during the study 12 months
Secondary Number of red blood cells transfused before and after treatment with eculizumab 12 months
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