NCT02435212 - Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload | Biotech Hunter

Enrollment

224

Participants

Timeline

Start Date

October 21, 2015

Primary Completion Date

May 31, 2018

Study Completion Date

January 15, 2024

Conditions

Transfusion-dependent Anemia

Interventions

DRUG

Deferasirox granule formulation

Deferasirox granules will be provided as stick packs containing 90 mg, 180 mg and 360 mg granules for oral use and will be administered based on body weight.

DRUG

Deferasirox DT formulation

Deferasirox DT will be provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use and will be administered based on body weight.

Trial Locations (43)

123

Novartis Investigative Site, Muscat

1006

Novartis Investigative Site, Tunis

1100

Novartis Investigative Site, Quezon

Novartis Investigative Site, Quezon City

1200

Novartis Investigative Site, Brussels

1527

Novartis Investigative Site, Sofia

2650

Novartis Investigative Site, Edegem

4002

Novartis Investigative Site, Plovdiv

4032

Novartis Investigative Site, Debrecen

9010

Novartis Investigative Site, Varna

10021

Novartis Investigative Site, New York

Weill Cornell Medical College SC -, New York

10467

Childrens Hospital at Montefiore, The Bronx

Novartis Investigative Site, The Bronx

10700

Novartis Investigative Site, Bangkok Noi

10990

Novartis Investigative Site, Pulau Pinang

16128

Novartis Investigative Site, Genova

21131

Novartis Investigative Site, Alexandria

29425

Medical Uni of South Carolina Medical Uni of South Carolina, Charleston

Novartis Investigative Site, Charleston

30342

Novartis Investigative Site, Atlanta

30450

Novartis Investigative Site, Ipoh

35040

Novartis Investigative Site, Izmir

38105

Novartis Investigative Site, Memphis

St. Jude Children's Research Hospital Memphis St Jude, Memphis

50200

Novartis Investigative Site, Muang

50589

Novartis Investigative Site, Kuala Lumpur

60611

Novartis Investigative Site, Chicago

75015

Novartis Investigative Site, Paris

80132

Novartis Investigative Site, Napoli

90127

Novartis Investigative Site, Palermo

90146

Novartis Investigative Site, Palermo

93586

Novartis Investigative Site, Kuching

94000

Novartis Investigative Site, Créteil

117198

Novartis Investigative Site, Moscow

700017

Novartis Investigative Site, Kolkata

94609-1809

Novartis Investigative Site, Oakland

19104 4399

Childrens Hospital of Philadelphia Onc. Dept, Philadelphia

Novartis Investigative Site, Philadelphia

PO BOX 213

Novartis Investigative Site, Hazmiyeh

0801

Novartis Investigative Site, Panama City

01330

Novartis Investigative Site, Adana

06100

Novartis Investigative Site, Ankara