A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in P… (NCT04958265) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
United States, Belgium41 participantsStarted 2021-11-17
Plain-language summary
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
Who can participate
Age range28 Days – 17 Years
SexALL
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Inclusion Criteria:
* Body weight \>= 5 kg at screening.
* Vaccination against Neisseria meningitis serotypes A, C, W, and Y; vaccination against serotype B, according to national vaccination recommendations.
* Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae, according to national vaccination recommendations.
* For patients continuing to receive other therapies concomitantly with crovalimab (e.g., immunosuppressants, corticosteroids, mammalian target of rapamycin inhibitor (mTORi), or calcineurin inhibitors): stable dose for \>=28 days prior to screening and up to the first crovalimab administration.
* For female participants of childbearing potential: an agreement to remain abstinent or use contraception.
* Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant.
* Onset of initial TMA presentation within 28 days prior to the first dose of crovalimab (for Naive Cohort only).
* Documented treatment with either eculizumab or ravulizumab (for Switch Cohort only).
* Clinical evidence of response to a C5 inhibitor (for Switch Cohort only).
* Poorly controlled TMA following treatment with another C5 inhibitor (for C5 SNP participants in the Pretreated Cohort only).
* Known C5 polymorphism (for C5 SNP participants in the Pretreated Cohort only).
Exclusion Criteria:
* TMA associated with non-aHUS related renal disease.
* Positive direct Coombs test.
* Chronic di…
What they're measuring
1
Percentage of Participants with complete TMA response (cTMAr) (Naive Cohort only)
Timeframe: Baseline up to Week 25 (after 24 weeks on treatment)