Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis

PHASE4CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

January 16, 2018

Primary Completion Date

December 5, 2019

Study Completion Date

December 5, 2019

Conditions
Iron Overload
Interventions
DRUG

Deferasirox

Deferosirox was provided in tablet forms of 90, 180 and 360mg. Tablets were crushed in the home environment and administered by sprinkling the full dose on to soft food to be consumed immediately.

Trial Locations (10)

123

Novartis Investigative Site, Muscat

9115

Novartis Investigative Site, Dubai

10700

Novartis Investigative Site, Bangkok Noi

44100

Novartis Investigative Site, Cona

44519

Novartis Investigative Site, Zagazig

50200

Novartis Investigative Site, Muang

80138

Novartis Investigative Site, Napoli

09121

Novartis Investigative Site, Cagliari

PO BOX 213

Novartis Investigative Site, Hazmiyeh

NW1 2BU

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY