NCT00600938 - Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload | Biotech Hunter

Enrollment

197

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions

Transfusional Iron OverloadTransfusional Hemosiderosis

Interventions

DRUG

Core Study: Deferasirox

20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day

DRUG

Core Study: Deferoxamine

50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week

DRUG

Extension: deferoxamine to deferasirox

40 mg/kg deferasirox once daily administered 30 minutes before taking food.

DRUG

Extension: deferasirox to deferoxamine

DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,

DRUG

Deferasirox

DRUG

Deferoxamine

Trial Locations (21)

3304

Novartis Investigative Site, Limassol

9115

Novartis Investigative Site, Dubai

10002

Novartis Investigative Site, Taipei

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

16128

Novartis Investigative Site, Genova

34093

Novartis Investigative Site, Istanbul

35040

Novartis Investigative Site, Izmir

530021

Novartis Investigative Site, Nanning

M5G 1X8

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Al Mansurah

Novartis Investigative Site, Cairo

Novartis Investigative Site, Hazmiyeh

09121

Novartis Investigative Site, Cagliari

01330

Novartis Investigative Site, Adana

06100

Novartis Investigative Site, Ankara

07070

Novartis Investigative Site, Antalya

LS9 7TF

Novartis Investigative Site, Leeds

N19 5NF

Novartis Investigative Site, London

NW1 2PJ

Novartis Investigative Site, London