Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload

PHASE3CompletedINTERVENTIONAL
Enrollment

1,683

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
ThalassemiaSickle Cell DiseaseDiamond Blackfan AnemiaMyelofibrosis
Interventions
DRUG

Deferasirox

125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.

Trial Locations (141)

11040

Schneider Children's Hospital, New Hyde Park

15213

Children's Hospitals of Pittsburgh, Pittsburgh

19803

Alfred I. Dupong Hospital for Children, Wilmington

23219

VCU Pediatric Hematology/Oncology, Richmond

23507

Children's Hospital of the Kings Daughters, Norfolk

31403

Backus Children's Hospital, Memorial Health University Medical Center, Savannah

32501

Hematalogy Oncology Associates, Pensacola

32901

Osler Medical, Inc., Melbourne

33607

Tampa Children's Hospital at St. Joseph's Hospital, Tampa

33612

James A. Haley Veterans Hospital, Tampa

39762

University of Mississippi Medical Center, Jackson

43205

PCTI, Columbus

45404

The Children's Medical Center of Dayton, Dayton

49048

Borgess Hospital, Kalamazoo

55405

Children's Hospitals and Clinics of Minnesota, Minneapolis

64108

Children's Mercy Hospital, Kansas City

70808

Hematalogy Oncology Clinic, Baton Rouge

72202

Arkansas Children's Hospital, UAMS College of Medicine, Little Rock

77030

Texas Children's Hospital, Houston

92123

Children's Hospital and Health Center of San Diego, San Diego

92868

Children's Hospital of Orange County, Orange

94305

Stanford University, Stanford

94704

Alta Bates Comprehensive Cancer Center, Berkeley

97239

Oregon Health & Science University, Portland

98195

University of Washington Seattle Cancer Care Alliance, Seattle

08903

The Cancer Institute of New Jersey, New Brunswick

17033-0850

Hershey Medical Center, Hershey

Unknown

Ziekenhuisnetwerk Antwerpen-AZ Middelheim, Antwerp

Centre Hospitalier Notre Dame et Reine, Charleroi

CHR de la Citadelle, Liège

Centre Hospitalier Chretien-Clinique Saint-Joseph, Montegnée

The Ottawa Hospital-General Campus, Ottawa

University of Alberta, Edmonton

CHUM-Hopital-Notre-Dame, Montreal

MUHC- Montreal Children's Hospital, Montreal

MUHC- Royal Victoria Hospital, Montreal

Hopital de l'Enfant-Jesus, Québec

The Hospital for Sick Children,, Toronto

Toronto General Hospital-Hemoglobinopathy, Toronto

Burrard Medical Building, Vancouver

Charite-Universitatsmedizin Berlin, Berlin

Universitatsklinikum Koln, Cologne

Universitaetsklinik Dusseldorf, Düsseldorf

Johann Wolfgang von Goethe Universitat, Frankfurt am Main

Georg-August-Universitat Gottingen, Göttingen

Universitatskrankenhaus Hamburg-Eppendorf, Hamburg

Medizinische Hochschule Hannover, Hanover

Klinikum Stuttgart Bismarckstrasse 8, Stuttgart

Universitatsklinikum Ulm, Ulm

Agia Sofia Hospital of Athens, Athens

General Hospital of Athens, Athens

Ippokration Hospital of Athens, Athens

General Hospital of Athens, Corfu

General Hospital of Korinthos, Corinth

General Hospital of Heraklion Benizeleio-Pananeio, Heraklion

University Hospital of Ioannina, Ioannina

General Hospital of Kalamata, Kalamata

Agia Sofia Hospital of Athens, Karditsa

General Hospital of Karditsa, Karditsa

General Hospital of Larisa Tsakalof 1, Larissa

General Hospital of Mytilini Vostaneio, Mytilene

General State Hospital of Nikaia St. Panteleimon, Nikaia

University Hospital of Patras, Pátrai

General Hospital of Thessaloniki Agios Pavlos, Thessaloniki

General Hospital Thessalonikis Hippokratio, Thessaloniki

General Hospital of Volos, Volos

General Hospital of Xanthi, Xánthi

Presidio Ospedale Muscatello, Augusta

A.O. Ospedale Policlinico Consorziale di Bari, Bari

Presidio Ospedaliero Antonio Perrino, Brindisi

Ospedale Regionale Microcitemie, Cagliari

Ospedale Di Venere, Carbonara di Bari

Azienda Ospedali Vittorio Emanuele, Ferrarotto e San Bambino, Catania

Presidio Ospedaliero S. Bambino, Catania

PresidioOspedaliero S. Luigi Curro, Catania

Azienda Ospedaliera Pugliese Cicaccio, Catanzaro

Ospedale Civile dell'Annunziata, Cosenza

Ospedale San Giuseppe, Empoli

Azienda Ospedaliera Universitaria di Ferrara, Ferrara

Azienda Ospedaliera A. Meyer, Florence

E.O. Ospedali Galliera, Genova

Ospedale Regionale Microcitemie, Itala

Ospedale Madonna delle Grazie, Matera

Az. Ospedaliera Universitaria Policlinico G. Martino, Messina

Fondazione Ospedale, Milan

Azienda Ospedaliero-Universitaria di Modena, Modena

AORN A. Cardarelli, Napoli

Azienda Ospedaliera Universitaria Federico II, Napoli

Azienda Ospedaliera V. Cervello, Palermo

Azienda Ospedaliera Villa Sofia-CTO, Palermo

Presidio Ospedaliero Giovanni di Cristina, Palermo

IRCCS Policlinico San Matteo, Pavia

Azienda Ospedaliera San Salvatore, Pesaro

Azienda Ospedaliero Universitaria Pisana, Pisa

Azienda Ospedaliera Civile- Maria Paterno, Ragusa

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria

Ospedale S. Eugenio, Roma

Ospedale nostra Signora di Bonaria, San Gavino Monreale- CA

Presidio Ospedaliero di Sassari-Ospedale SS, Sassari

Azienda Ospedaliera Ospedali Civili Riuniti di Sciacca, Sciacca

Ospedale Umberto I, Talassemie

Presidio Ospedaliero Centrale, Taranto

Ospedale Infantile Regina Margherita, Torino

AMC, Amsterdam

Catharina-ziekenhuis, Eindhoven

Erasmus MC, Rotterdam

Erasmus Medisch Centrum, locatie Sophia, Rotterdam

Haga Ziekenhuis, The Hague

Hospital de Torrecardenas, Almería

Hospital Infanta Cristina, Badajoz

Hospital Cruces, Barakaldo

Hospital Puerta del Mar, Cadiz

Hospital De Gran Canaria, Canara

Hospital Universitario La Paz, Madrid

Althaia : Xarxa Assistencial de Manresa, Manresa

Hospital Universitario Marques de Valdecilla, Santander

Hospital Virgen de la Salud, Toledo

Hospital Universitario La Fe, Valencia

Hospital Xeral de Vigo, Vigo

Kaohsiung Medical University Hospital, Kaohsiung City

Mackay Memorial Hospital, Taipei

National Taiwan University Hospital, Taipei

Chang Gung Children's Hospital, Taoyuan District

Tao-yuan General Hospital, Tau-Yuan County

Phramongkutklao Hospital, Bangkok

Ramathibodi Hospital, Bangkok

Songklanagarind Hospital, Bangkok

Srinagarind Hospital, Khon Kaen

Cukurova Universitesi, Adana

Hacettepe Universitesi, Ankara

Akdeniz Universitesi, Antalya

Gaziantep Universitesi, Gaziantep

Suleyman Demirel, Isparta

Istanbul Universitesi, Istanbul

Ege Universitesi Tip Fakultesi, Izmir

Erciyes Universitesi, Kayseri

Evelina Hospital St. Thomas' Hospital, London

North Middlesex University Hospital, London

The Royal Hospital London, London

Whittington Hospital, London

St. George's Hospital, Tooting

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY