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ACTIVE NOT RECRUITING
NCT04958265
PHASE3

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric 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 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

Interventions

DRUG

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