Open-label, Multicenter Study Assessing Preference for Deferasirox Film-coated Tablet Compared to Dispersible Tablet

PHASE2CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

July 27, 2017

Primary Completion Date

January 29, 2020

Study Completion Date

March 11, 2021

Conditions
Transfusion-dependent ThalassemiaNon-transfusion-dependent Thalassemia
Interventions
DRUG

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."

DRUG

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)."

Trial Locations (17)

10102

Novartis Investigative Site, Rabat

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok Noi

Novartis Investigative Site, Bangkoknoi

11117

Novartis Investigative Site, Riyadh

11562

Novartis Investigative Site, Cairo

21131

Novartis Investigative Site, Alexandria

21159

Novartis Investigative Site, Jeddah

21589

Novartis Investigative Site, Jeddah

34093

Novartis Investigative Site, Istanbul

44519

Novartis Investigative Site, Zagazig

PO BOX 213

Novartis Investigative Site, Hazmiyeh

Unknown

Novartis Investigative Site, Al Ahsa

Novartis Investigative Site, Hanoi

06100

Novartis Investigative Site, Ankara

07070

Novartis Investigative Site, Antalya

DISTRICT 1

Novartis Investigative Site, Ho Chi Minh City

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY