A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)
Primary Objective
The objective for this study is to evaluate the effect of crovalimab on treatment-naive patients based on complete response to treatment based on lab measurements
Description
SIngle-arm, uncontrolled, multicenter, global Phase III study designed to evaluate the efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of crovalimab in patieths with aHUS.
Details
Age
Child to Adult
Eligibility
Age greater than or equal to 12 years, Weight greater than or equal to 40 kilograms.Vaccination against Neisseria meningitidis A, C, W, and Y, Haemophilus influenzae type B, Streptococcus pneumoniae, and SARS-CoV-2. For patients receiving other therapies, stable dose for 28 days or more and only if part of established regimens. Adequate hepatic function. Patients may not be pregnant and must agree to either be abstinent or use contraception.
Locations
Childrens Hospital Colorado
Principal Investigator
Bradley Dixon
Study ID
Protocol Number: 20-2595
Categories
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