96
Participants
Start Date
July 7, 2022
Primary Completion Date
December 10, 2024
Study Completion Date
July 24, 2025
NDec - oral decitabine-tetrahydrouridine
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
HU - Hydroxyurea
Participants will get capsules daily (oral administration) according to local labelling
Placebo
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
Sultan Qaboos University Hospital, Muscat
Charlotte Maxeke Johannesburg Academic Hospital, Parktown, Johannesburg
Mount Sinai School of Medicine, New York
Aghia Sophia Childrens' Hospital, Goudi
St Christopher Hosp for Child, Philadelphia
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico, Milan
Gen Univ Hospital of Patras, Thalassemia/Hemoglobinopathies, Pátrai
Hospital Universitario La Paz, Madrid
Mersin University Medical Faculty Hospital, Hematology, Mersin
Azienda Ospedale Universita Padova, Padua
Azienda Ospedaliera Universitaria Integrata Verona Policlinico GB Rossi - Borgo Roma, Verona
Policlinico GB Rossi, Verona
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3, Grenoble
Mississippi Center Advanced Medicine, Madison
General Hospital Of Larissa Koutlibaneio And Triantafylleio, Larissa
University Of Illinois at Chicago, Chicago
Hospices Civils de Lyon-Hopital Edouard Herriot, Lyon
NRS Medical College & Hospital, Kolkata
University of Oklahoma Health Sciences Center_Oklahoma City, Oklahoma City
Univ Texas HSC-Houston, Houston
Clinical and Transl Res Center, Aurora
Cure 4 the Kids Foundation, Las Vegas
UCSF Oakland Benioff Children's Hospital, Oakland
SSG Hospital, Baroda, Vadodara
SSG Hospital, Baroda, Vadodara
Nirmal Hospital Pvt. Ltd., Surat
BAPS Pramukh Swami Hospital, Surat
KIMS - Kingsway Hospital, Nagpur
Government Medical College and Hospital, Nagpur
Government Medical College and Super Speciality Hospital, Nagpur, Nagpur
Victoria Hospital (Bangalore Medical College and Research Institute), Bangalore
Christian Medical College Hospital, Vellore, Ranipet
Government Medical College, Kozhikode, Kozhikode
NRS Medical College & Hospital, Kolkata
IMS and SUM Hospital, Bhubaneswar
S.C.B. Medical College, Cuttack
Harbor-UCLA Medical Center, Torrance
LHSC - Victoria Hospital, London
Toronto General Hospital, Liver Clinic, Toronto
Toronto General Hospital, Liver Clinic, Toronto
McGill University Health Centre, Montreal
Acibadem Adana Hastanesi, Adana
Cukurova Universitesi, Adana
Hacettepe University Hematology, Ankara
University Hospital of Wales, Cardiff
Central Middlesex Hospital, London
Guy's Hosptial, London
Kings College Hospital, London
Lead Sponsor
Novo Nordisk A/S
INDUSTRY