A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
Study summary
This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Complete Thormbotic Microangiopathy Response (cTMAr) — Baseline up to Week 25 (after 24 weeks on treatment)
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| Univ of CA San Francisco | San Francisco | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| Emory Children's Center | Atlanta | Georgia | |
| Washington University | St Louis | Missouri | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| UT Health Science Center | San Antonio | Texas | |
| UZ Leuven Gasthuisberg | Leuven | Belgium | |
| Santa Casa de Misericordia | Belo Horizonte | Minas Gerais | |
| UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu | Botucatu | São Paulo | |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | |
| Vancouver General Hospital | Vancouver | British Columbia | |
| Peking University First Hospital | Beijing | China | |
| Hopital Lapeyronie | 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 | |
| All India Institute Of Medical Sciences (AIIMS) | New Delhi | National Capital Territory of Delhi | |
| Rambam Medical Center | Haifa | Israel | |
| Rabin Medical Center | Petah Tikva | Israel | |
| Sheba MC | Ramat Gan | Israel | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio | |
| A.O. Universitaria S. Martino Di Genova | Genoa | Liguria | |
| 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) | |
| Instituto Nacional de Ciencias | Mexico City | Mexico CITY (federal District) | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | |
| Hospital de Especialidades Puerta de Hierro S.A de C.V. | Zapopan | Mexico | |
| Instytut ?Centrum Zdrowia Matki Polki | Lodz | Poland | |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | Spain | |
| 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) |
+ 2 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04861259 on ClinicalTrials.gov ↗ ← All trials in Spain