Research Project
Project Title: |
A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME |
Project Type: |
Clinical Trial, Enrolment ongoing Adjunct biobank: DNA, Serum, Plasma, Urine |
Disease group(s): |
Thrombotic microangiopathies |
Project Summary: |
This study will evaluate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of crovalimab in patients with atypical hemolytic uremic syndrome (aHUS), aged  28 days to  18 years, and weighing  5 kg. This study includes three cohorts: one for complement inhibitor-naive patients, one for patients who switch from eculizumab or ravulizumab to crovalimab, and one for patients who were previously treated with eculizumab or ravulizumab and discontinued it, who may or may not have a known C5 polymorphism and may have responded poorly to previous treatment. |
Lead principal investigator(s): |
Giovanni Montini, Milan |
Project Period: |
12/2021 - 12/2050 |
Sponsors: |
Industry |
Project web page: |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002475-35/IT |
EudraCT Nr.: |
2023-505638-82-00 |
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