23
Participants
Start Date
February 24, 2020
Primary Completion Date
April 5, 2022
Study Completion Date
August 19, 2022
RZ358 Sequential Group Cohort 1
IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks)
RZ358 Sequential Group Cohort 2
IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks)
RZ358 Sequential Group Cohort 3
IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks)
RZ358 Sequential Group Cohort 4
IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks)
Odense University Hospital, Odense
"Medical University of Varna UMHAT St. Marina", Varna
The Children's Hospital of Philadelphia, Philadelphia
SBÜ Gazi Yaşargil Eğitim ve Araştirma Hastanesi, Kayapınar
Magdeburg University Clinic Center (Otto-von-Guericke Universität), Magdeburg
Cook Children's Medical Center, Fort Worth
Hadassah Har Hazofim MC - Division of Pediatric Endocrinology, Jerusalem
Endocrinology research center, Moscow
Edmond & Lilly Safra's Children Hospital, Ramat Gan
"SHAT Children diseases Prof. Dr. Ivan Mitov", Sofia
Adana Cukurova University Balcalı Hospital, Sarıçam
Erzurum City Hospital, Yakutiye
Great Ormond Street Hospital, London
Research Institute of the McGill University Health Centre, Monteral
"LTD Pediatric Surgery Centre", Tbilisi
Hospital Universitari Vall d' Hebron, Barcelona
Hacettepe University, Çankaya
Lead Sponsor
Rezolute
OTHER