86
Participants
Start Date
February 14, 2022
Primary Completion Date
October 31, 2027
Study Completion Date
October 31, 2027
JR-141
IV infusion, 2.0 mg/kg/week
Idursulfase
IV infusion
JR-141 or Idursulfase
"The subjects who have achieved the pre-specified criteria\* are able to change the drug.~\*If a subject in Idursulfase group shows decline in their neurocognitive outcome, idursulfase can be switched to JR-141.~If a subject in JR-141 group shows decline in their peripheral outcome, JR-141 will be switched to idursulfase."
Columbia University, New York
Children's Hospital of Philadelphia, Philadelphia
University of Minnesota, Minneapolis
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
UCSF Benioff Children's Hospital Oakland, Oakland
Phoenix Children's Hospital, Phoenix
University of North Carolina at Chapel Hill Medical School Wing E, Chapel Hill
Hospital Universitario Austral, Buenos Aires
Hospital de Clínicas de Porto Alegre, Porto Alegre
Instituto de Medicina Integral Prof. Fernando Figueira - Imip, Recife
Instituto de Genética e Erros Inatos do Metabolismo, São Paulo
Fundación Cardio Infantil - Instituto de Cardiología, Bogotá
Hôpital Femme Mère Enfant, Bron
Chu De Montpellier Hopital Gui De Chauliac, Montpellier
Hôpital Armand Trousseau, Paris
Universitätsklinikum Giessen, Giessen
Universitätsklinikum Hamburg-Eppendorf, Hamburg
SphinCS GmbH, Höchheim
Universitätsmedizin Mainz, Mainz
Ha'Emek Medical Center, Afula
The Chaim Sheba Medical Center, Ramat Gan
Fondazione IRCCS San Gerardo dei Tintori, Monza
Osp. Pediatrico Bambino Gesù, IRCCS, Rome
Uniwersytecki Szpital Dziecięcy, Krakow
Hospital Sant Joan de Déu, Barcelona
Hospital Universitario Virgen del Rocio, Seville
Gazi University Medicine Faculty Hospital, Ankara
Ege University Children Hospital, Izmir
Great Ormond Street Hospital for Children NHS Trust - Metabolic Medicine, London
Lead Sponsor
JCR Pharmaceuticals Co., Ltd.
INDUSTRY