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A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Sponsor: Hoffmann-La Roche
Summary
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
Official 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 (aHUS)
Key Details
Gender
All
Age Range
28 Days - 17 Years
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2021-11-17
Completion Date
2029-05-19
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Crovalimab
Crovalimab will be administered at a dose of 1000 mg intravenously (IV) (for participants weighing =\> 40 to \<100 kg) or 1500 mg IV (for participants weighing \>=100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants weighing =\> 40 to \<100 kg) or 1020 mg SC (for participants weighing \>=100 kg). Enrollment of participants weighing \<40 kg will be staggered using two weight-based dose confirmation groups (Group 1 participants weighing \>=20 kg to \<40 kg, followed by Group 2 participants weighing \>=5 kg to \<20 kg). All participants will receive an initial IV loading dose, which will be followed by SC dosing at either Q2W or Q4W intervals (depending on body weight), until study completion.
Locations (20)
Children's Hospital Colorado
Aurora, Colorado, United States
University of Nebraska
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
UZ Gent
Ghent, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Inst. Da Criança- Faculdade de Medicina Usp
São Paulo, São Paulo, Brazil
CHU Sainte-Justine
Montreal, Quebec, Canada
Peking University First Hospital
Beijing, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
The children's hospital , Zhejiang university school of medicine
Hangzhou, China
Hôpital Arnaud de Villeneuve
Montpellier, France
Gh Necker Enfants Malades
Paris, France
Institute of Kidney Diseases and Research Centre
Ahmedabad, Gujarat, India
Medanta-The Medicity
Gurgaon, Haryana, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Aichi Children?s Health and Medical Center
Aichi, Japan
Chiba Children's Hospital
Chibashi, Chibaken, Japan
Hospital de Especialidades Puerta de Hierro S.A de C.V.
Zapopan, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Instytut ?Centrum Zdrowia Matki Polki
Lodz, Poland