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ACTIVE NOT RECRUITING
NCT04861259
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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)