148
Participants
Start Date
July 27, 2017
Primary Completion Date
January 29, 2020
Study Completion Date
March 11, 2021
Deferasirox dispersable tablet (DT)
"Deferasirox DT was provided as 125 mg, 250 mg, 500 mg dispersible tablets for oral use. The strengths provided in an individual country could differ and reflected the strengths available commercially in each country.~For iron chelation naive participants, the starting dose on Baseline Day 1 was 20 mg/kg/day in TDT and 10 mg/kg/day in NTDT.~For iron chelation (deferoxamine and/or deferiprone) pre-treated participants, the starting dose was equivalent to the dose of deferoxamine received (for participants pre-treated with deferoxamine) and based on their serum ferritin levels (for participants pre-treated with deferiprone).~Participants took deferasirox DT once daily for 24 weeks (core phase). The required number of deferasirox DT tablets were to be dispersed with gentle stirring in a glass of water."
Deferasirox film coated tablet (FCT)
"Deferasirox FCT was provided as 90 mg, 180 mg, 360 mg film coated tablets for oral use. The FCT starting dose on Week 25 was 14 mg/kg/day in TDT and 7 mg/kg/day in NTDT.~Participants took deferasirox FCT once daily for 24 weeks during the core phase and up to 48 weeks during the extension phase. For patients with difficulties in swallowing deferasirox FCT, it was allowed to crush the film-coated tablets and administer the study drug by sprinkling the full dose on soft food (like yogurt or apple puree)."
Novartis Investigative Site, Rabat
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok Noi
Novartis Investigative Site, Bangkoknoi
Novartis Investigative Site, Riyadh
Novartis Investigative Site, Cairo
Novartis Investigative Site, Alexandria
Novartis Investigative Site, Jeddah
Novartis Investigative Site, Jeddah
Novartis Investigative Site, Istanbul
Novartis Investigative Site, Zagazig
Novartis Investigative Site, Hazmiyeh
Novartis Investigative Site, Al Ahsa
Novartis Investigative Site, Hanoi
Novartis Investigative Site, Ankara
Novartis Investigative Site, Antalya
Novartis Investigative Site, Ho Chi Minh City
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY