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A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Sponsor: Hoffmann-La Roche
Summary
This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2021-10-22
Completion Date
2029-08-20
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Crovalimab
Crovalimab will be administered at a dose of 1000 milligrams (mg) intravenous (IV) (for participants with body weight at least 40 (\>=) and up to 100 kilograms (kg) or 1500 mg IV (for participants with body weight \>=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and every 4 weeks (Q4W) thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight \>= 40kg to \<100kg) or 1020 mg SC (for participants with body weight \>=100kg).
Locations (43)
Univ of CA San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Emory Children's Center
Atlanta, Georgia, United States
Washington University
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
UT Health Science Center
San Antonio, Texas, United States
UZ Leuven Gasthuisberg
Leuven, Belgium
Santa Casa de Misericordia
Belo Horizonte, Minas Gerais, Brazil
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Vancouver General Hospital
Vancouver, British Columbia, Canada
Peking University First Hospital
Beijing, China
Hopital Lapeyronie
Montpellier, France
Hôpital Arnaud de Villeneuve
Montpellier, France
Hôpital Robert Debré
Paris, France
Hopital Tenon
Paris, France
Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne, Germany
Universitätsklinikum Essen
Essen, Germany
Klinik für Nephrologie des Universitätsklinikum Essen
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely
Budapest, Hungary
Medanta-The Medicity
Gurgaon, Haryana, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Rambam Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba MC
Ramat Gan, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, Italy
Nagoya University Hospital
Aichi, Japan
Saitama Medical University Hospital
Saitama, Japan
The University of Tokyo Hospital
Tokyo, Japan
Hospital General de México
Distrito Federal, Mexico CITY (federal District), Mexico
Instituto Nacional de Ciencias
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Hospital de Especialidades Puerta de Hierro S.A de C.V.
Zapopan, Mexico
Instytut ?Centrum Zdrowia Matki Polki
Lodz, Poland
Hospital Clinic i Provincial
Barcelona, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Istanbul University Istanbul Medical Faculty
Istanbul, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye)
Malatya Park Hospital
Malatya, Turkey (Türkiye)