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A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
EU CTIS ID: 2023-505638-82-00
What this study is testing
To evaluate the effect of crovalimab in complement inhibitor treatment-naive (Naive) patients
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment in accordance with current local guidelines or standard of care, as applicable in patients with complement deficiency (for ALL cohorts)
- For female patients of childbearing potential, an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (for ALL cohorts)
- Onset of initial TMA presentation, within 28 days prior to the first dose of crovalimab (For naïve cohort only)
- Clinical evidence of response to either eculizumab or ravulizumab, as documented by a platelet count ≥LLN, LDH ≤ULN, and stable (decrease or increase of ≤20%) or improving creatinine at two consecutive measurements at least 4 weeks apart prior to Week 1 Day 1 of crovalimab treatment. (For switch cohort only)
- Known C5 polymorphism (e.g., Arg885) (For C5SNP cohort only)
You likely can't join if
- TMA associated with non-aHUS-related renal disease
- History of a kidney disease other than aHUS, affecting renal function
- Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome
- Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration
- History of Neisseria meningitidis infection within 6 months of study enrollment
- History of malignancy within 5 years prior to screening and up to the first crovalimab administration
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Japan
- Mexico
- Israel
- Brazil
- China
- Canada
- South Africa
- India
- Peru
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Japan; Mexico; Israel; Brazil and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.