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

Primary Purpose

Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Deferasirox
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thalassemia focused on measuring Deferasirox, Congenital Anemias, Anemias, Red Blood Cell Disorders, Chronic Iron Overload, Transfusional Iron Overload, Iron Chelators, Oral Iron Chelators, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia, Myelofibrosis, ICL670A

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients greater than or equal to 2 years of age Documented congenital disorder of red blood cells (e.g., β-thalassemia major, sickle cell anemia, diamond-blackfan anemia) requiring ongoing blood transfusions Cannot be adequately treated with a locally approved iron chelator due to one of the following reasons: Documented non-compliance, defined as having taken less than 50% of the prescribed chelation therapy doses in the 12 months prior to study entry Contraindications, unacceptable toxicities and/or documented poor response to locally approved iron chelators despite proper compliance History of at least 20 blood transfusions (equivalent to 100 mL/kg of packed red blood cells (PRBC]) Serum ferritin value greater than or equal to 1000 µg/L Ability to comply with all study-related procedures, medications, and evaluations Exclusion Criteria: Ongoing treatment with another iron chelator (Any other iron chelation therapy must be discontinued at least 24 hours prior to study entry.) Patients who meet the eligibility criteria for any other ongoing Novartis sponsored clinical study protocol with deferasirox and who have geographic access to these sites Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox Serum creatinine above the upper limit of normal at screening. Patients with ALT ≥ 500 U/L at screening. Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline Pregnancy (as indicated by serum β-HCG pregnancy test at screening for all female patients with the potential to become pregnant) and patients who are breastfeeding Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Arkansas Children's Hospital, UAMS College of Medicine
  • Alta Bates Comprehensive Cancer Center
  • Children's Hospital of Orange County
  • Children's Hospital and Health Center of San Diego
  • Stanford University
  • Alfred I. Dupong Hospital for Children
  • Osler Medical, Inc.
  • Hematalogy Oncology Associates
  • Tampa Children's Hospital at St. Joseph's Hospital
  • James A. Haley Veterans Hospital
  • Backus Children's Hospital, Memorial Health University Medical Center
  • Hematalogy Oncology Clinic
  • Borgess Hospital
  • Children's Hospitals and Clinics of Minnesota
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • The Cancer Institute of New Jersey
  • Schneider Children's Hospital
  • PCTI
  • The Children's Medical Center of Dayton
  • Oregon Health & Science University
  • Hershey Medical Center
  • Children's Hospitals of Pittsburgh
  • Texas Children's Hospital
  • Children's Hospital of the Kings Daughters
  • VCU Pediatric Hematology/Oncology
  • University of Washington Seattle Cancer Care Alliance
  • Ziekenhuisnetwerk Antwerpen-AZ Middelheim
  • Centre Hospitalier Notre Dame et Reine
  • CHR de la Citadelle
  • Centre Hospitalier Chretien-Clinique Saint-Joseph
  • The Ottawa Hospital-General Campus
  • University of Alberta
  • CHUM-Hopital-Notre-Dame
  • MUHC- Montreal Children's Hospital
  • MUHC- Royal Victoria Hospital
  • Hopital de l'Enfant-Jesus
  • The Hospital for Sick Children,
  • Toronto General Hospital-Hemoglobinopathy
  • Burrard Medical Building
  • Charite-Universitatsmedizin Berlin
  • Universitaetsklinik Dusseldorf
  • Johann Wolfgang von Goethe Universitat
  • Georg-August-Universitat Gottingen
  • Universitatskrankenhaus Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitatsklinikum Koln
  • Klinikum Stuttgart Bismarckstrasse 8
  • Universitatsklinikum Ulm
  • Agia Sofia Hospital of Athens
  • General Hospital of Athens
  • Ippokration Hospital of Athens
  • General Hospital of Heraklion Benizeleio-Pananeio
  • University Hospital of Ioannina
  • General Hospital of Kalamata
  • Agia Sofia Hospital of Athens
  • General Hospital of Karditsa
  • General Hospital of Athens
  • General Hospital of Korinthos
  • General Hospital of Larisa Tsakalof 1
  • General Hospital of Mytilini Vostaneio
  • General State Hospital of Nikaia St. Panteleimon
  • University Hospital of Patras
  • General Hospital of Thessaloniki Agios Pavlos
  • General Hospital Thessalonikis Hippokratio
  • General Hospital of Volos
  • General Hospital of Xanthi
  • Presidio Ospedale Muscatello
  • A.O. Ospedale Policlinico Consorziale di Bari
  • Presidio Ospedaliero Antonio Perrino
  • Ospedale Regionale Microcitemie
  • Ospedale Di Venere
  • Azienda Ospedali Vittorio Emanuele, Ferrarotto e San Bambino
  • Presidio Ospedaliero S. Bambino
  • PresidioOspedaliero S. Luigi Curro
  • Azienda Ospedaliera Pugliese Cicaccio
  • Ospedale Civile dell'Annunziata
  • Ospedale San Giuseppe
  • Azienda Ospedaliera Universitaria di Ferrara
  • Azienda Ospedaliera A. Meyer
  • E.O. Ospedali Galliera
  • Ospedale Regionale Microcitemie
  • Ospedale Madonna delle Grazie
  • Az. Ospedaliera Universitaria Policlinico G. Martino
  • Fondazione Ospedale
  • Azienda Ospedaliero-Universitaria di Modena
  • AORN A. Cardarelli
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliera V. Cervello
  • Azienda Ospedaliera Villa Sofia-CTO
  • Presidio Ospedaliero Giovanni di Cristina
  • IRCCS Policlinico San Matteo
  • Azienda Ospedaliera San Salvatore
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Civile- Maria Paterno
  • Azienda Ospedaliera Bianchi-Melacrino-Morelli
  • Ospedale S. Eugenio
  • Ospedale nostra Signora di Bonaria
  • Presidio Ospedaliero di Sassari-Ospedale SS
  • Azienda Ospedaliera Ospedali Civili Riuniti di Sciacca
  • Ospedale Umberto I
  • Presidio Ospedaliero Centrale
  • Ospedale Infantile Regina Margherita
  • AMC
  • Haga Ziekenhuis
  • Catharina-ziekenhuis
  • Erasmus MC
  • Erasmus Medisch Centrum, locatie Sophia
  • Hospital de Torrecardenas
  • Hospital Infanta Cristina
  • Hospital Cruces
  • Hospital Puerta del Mar
  • Hospital De Gran Canaria
  • Hospital Universitario La Paz
  • Althaia : Xarxa Assistencial de Manresa
  • Hospital Universitario Marques de Valdecilla
  • Hospital Virgen de la Salud
  • Hospital Universitario La Fe
  • Hospital Xeral de Vigo
  • Kaohsiung Medical University Hospital
  • Mackay Memorial Hospital
  • National Taiwan University Hospital
  • Chang Gung Children's Hospital
  • Tao-yuan General Hospital
  • Phramongkutklao Hospital
  • Ramathibodi Hospital
  • Songklanagarind Hospital
  • Srinagarind Hospital
  • Cukurova Universitesi
  • Hacettepe Universitesi
  • Akdeniz Universitesi
  • Gaziantep Universitesi
  • Suleyman Demirel
  • Istanbul Universitesi
  • Ege Universitesi Tip Fakultesi
  • Erciyes Universitesi
  • Evelina Hospital St. Thomas' Hospital
  • North Middlesex University Hospital
  • The Royal Hospital London
  • Whittington Hospital
  • St. George's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deferasirox

Arm Description

Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Starting dose was determined by the frequency of blood transfusions and recommended initial daily dose of deferasirox is 20 mg/kg body weight for patients receiving blood transfusion, 10 mg/kg for patients receiving less frequent transfusion/exchange transfusion and 30 mg/kg for patients receiving more frequent blood transfusions.

Outcomes

Primary Outcome Measures

Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events
Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.

Secondary Outcome Measures

The Change in Serum Ferritin Values From Baseline Through Completion of the Study
The number of participants with Improvement, No Change or Worsening in Serum ferritin category levels at the end of the study compared to baseline. Serum ferritin levels in µg/L were divided into to 6 categories: (<1000), (1000-<2500), (2500-<4000), (4000-<5500), (5500-<7000) and (>=7000). Improvement was defined as a shift to a lower category at the end of study compared to the category at baseline. Worsening was defined as a shift to a higher category at the end of the study compared to the category at baseline. No change was no change in category at end of study from baseline.

Full Information

First Posted
October 6, 2005
Last Updated
June 3, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00235391
Brief Title
Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload
Official Title
A Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Treated With Other Locally Approved Iron Chelators
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia, Myelofibrosis
Keywords
Deferasirox, Congenital Anemias, Anemias, Red Blood Cell Disorders, Chronic Iron Overload, Transfusional Iron Overload, Iron Chelators, Oral Iron Chelators, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia, Myelofibrosis, ICL670A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1683 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deferasirox
Arm Type
Experimental
Arm Description
Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Starting dose was determined by the frequency of blood transfusions and recommended initial daily dose of deferasirox is 20 mg/kg body weight for patients receiving blood transfusion, 10 mg/kg for patients receiving less frequent transfusion/exchange transfusion and 30 mg/kg for patients receiving more frequent blood transfusions.
Intervention Type
Drug
Intervention Name(s)
Deferasirox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events
Description
Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.
Time Frame
Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)
Secondary Outcome Measure Information:
Title
The Change in Serum Ferritin Values From Baseline Through Completion of the Study
Description
The number of participants with Improvement, No Change or Worsening in Serum ferritin category levels at the end of the study compared to baseline. Serum ferritin levels in µg/L were divided into to 6 categories: (<1000), (1000-<2500), (2500-<4000), (4000-<5500), (5500-<7000) and (>=7000). Improvement was defined as a shift to a lower category at the end of study compared to the category at baseline. Worsening was defined as a shift to a higher category at the end of the study compared to the category at baseline. No change was no change in category at end of study from baseline.
Time Frame
Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients greater than or equal to 2 years of age Documented congenital disorder of red blood cells (e.g., β-thalassemia major, sickle cell anemia, diamond-blackfan anemia) requiring ongoing blood transfusions Cannot be adequately treated with a locally approved iron chelator due to one of the following reasons: Documented non-compliance, defined as having taken less than 50% of the prescribed chelation therapy doses in the 12 months prior to study entry Contraindications, unacceptable toxicities and/or documented poor response to locally approved iron chelators despite proper compliance History of at least 20 blood transfusions (equivalent to 100 mL/kg of packed red blood cells (PRBC]) Serum ferritin value greater than or equal to 1000 µg/L Ability to comply with all study-related procedures, medications, and evaluations Exclusion Criteria: Ongoing treatment with another iron chelator (Any other iron chelation therapy must be discontinued at least 24 hours prior to study entry.) Patients who meet the eligibility criteria for any other ongoing Novartis sponsored clinical study protocol with deferasirox and who have geographic access to these sites Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox Serum creatinine above the upper limit of normal at screening. Patients with ALT ≥ 500 U/L at screening. Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline Pregnancy (as indicated by serum β-HCG pregnancy test at screening for all female patients with the potential to become pregnant) and patients who are breastfeeding Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Children's Hospital, UAMS College of Medicine
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children's Hospital and Health Center of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Alfred I. Dupong Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Osler Medical, Inc.
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Hematalogy Oncology Associates
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Tampa Children's Hospital at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
James A. Haley Veterans Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Backus Children's Hospital, Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403
Country
United States
Facility Name
Hematalogy Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Borgess Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55405
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39762
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
PCTI
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Children's Medical Center of Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospitals of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital of the Kings Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
VCU Pediatric Hematology/Oncology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
University of Washington Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Ziekenhuisnetwerk Antwerpen-AZ Middelheim
City
Antwerpen
Country
Belgium
Facility Name
Centre Hospitalier Notre Dame et Reine
City
Charleroi
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
Country
Belgium
Facility Name
Centre Hospitalier Chretien-Clinique Saint-Joseph
City
Montegnee
Country
Belgium
Facility Name
The Ottawa Hospital-General Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
University of Alberta
City
Edmonton
Country
Canada
Facility Name
CHUM-Hopital-Notre-Dame
City
Montreal
Country
Canada
Facility Name
MUHC- Montreal Children's Hospital
City
Montreal
Country
Canada
Facility Name
MUHC- Royal Victoria Hospital
City
Montreal
Country
Canada
Facility Name
Hopital de l'Enfant-Jesus
City
Quebec
Country
Canada
Facility Name
The Hospital for Sick Children,
City
Toronto
Country
Canada
Facility Name
Toronto General Hospital-Hemoglobinopathy
City
Toronto
Country
Canada
Facility Name
Burrard Medical Building
City
Vancouver
Country
Canada
Facility Name
Charite-Universitatsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Universitaetsklinik Dusseldorf
City
Duesseldorf
Country
Germany
Facility Name
Johann Wolfgang von Goethe Universitat
City
Frankfurt am Main
Country
Germany
Facility Name
Georg-August-Universitat Gottingen
City
Gottingen
Country
Germany
Facility Name
Universitatskrankenhaus Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Köln
Country
Germany
Facility Name
Klinikum Stuttgart Bismarckstrasse 8
City
Stuttgart
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Agia Sofia Hospital of Athens
City
Athens
Country
Greece
Facility Name
General Hospital of Athens
City
Athens
Country
Greece
Facility Name
Ippokration Hospital of Athens
City
Athens
Country
Greece
Facility Name
General Hospital of Heraklion Benizeleio-Pananeio
City
Heraklion
Country
Greece
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
Facility Name
General Hospital of Kalamata
City
Kalamata
Country
Greece
Facility Name
Agia Sofia Hospital of Athens
City
Karditsa
Country
Greece
Facility Name
General Hospital of Karditsa
City
Karditsa
Country
Greece
Facility Name
General Hospital of Athens
City
Kerkyra
Country
Greece
Facility Name
General Hospital of Korinthos
City
Korinthos
Country
Greece
Facility Name
General Hospital of Larisa Tsakalof 1
City
Larisa
Country
Greece
Facility Name
General Hospital of Mytilini Vostaneio
City
Mytilini
Country
Greece
Facility Name
General State Hospital of Nikaia St. Panteleimon
City
Nikaia
Country
Greece
Facility Name
University Hospital of Patras
City
Patra
Country
Greece
Facility Name
General Hospital of Thessaloniki Agios Pavlos
City
Thessaloniki
Country
Greece
Facility Name
General Hospital Thessalonikis Hippokratio
City
Thessaloniki
Country
Greece
Facility Name
General Hospital of Volos
City
Volos
Country
Greece
Facility Name
General Hospital of Xanthi
City
Xanthi
Country
Greece
Facility Name
Presidio Ospedale Muscatello
City
Augusta
Country
Italy
Facility Name
A.O. Ospedale Policlinico Consorziale di Bari
City
Bari
Country
Italy
Facility Name
Presidio Ospedaliero Antonio Perrino
City
Brindisi
Country
Italy
Facility Name
Ospedale Regionale Microcitemie
City
Cagliari
Country
Italy
Facility Name
Ospedale Di Venere
City
Carbonara di Bari
Country
Italy
Facility Name
Azienda Ospedali Vittorio Emanuele, Ferrarotto e San Bambino
City
Catania
Country
Italy
Facility Name
Presidio Ospedaliero S. Bambino
City
Catania
Country
Italy
Facility Name
PresidioOspedaliero S. Luigi Curro
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Pugliese Cicaccio
City
Catanzaro
Country
Italy
Facility Name
Ospedale Civile dell'Annunziata
City
Cosenza
Country
Italy
Facility Name
Ospedale San Giuseppe
City
Empoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Ferrara
City
Ferrara
Country
Italy
Facility Name
Azienda Ospedaliera A. Meyer
City
Firenze
Country
Italy
Facility Name
E.O. Ospedali Galliera
City
Genova
Country
Italy
Facility Name
Ospedale Regionale Microcitemie
City
Itala
Country
Italy
Facility Name
Ospedale Madonna delle Grazie
City
Matera
Country
Italy
Facility Name
Az. Ospedaliera Universitaria Policlinico G. Martino
City
Messina
Country
Italy
Facility Name
Fondazione Ospedale
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena
City
Modena
Country
Italy
Facility Name
AORN A. Cardarelli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera V. Cervello
City
Palermo
Country
Italy
Facility Name
Azienda Ospedaliera Villa Sofia-CTO
City
Palermo
Country
Italy
Facility Name
Presidio Ospedaliero Giovanni di Cristina
City
Palermo
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliera San Salvatore
City
Pesaro
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
Country
Italy
Facility Name
Azienda Ospedaliera Civile- Maria Paterno
City
Ragusa
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli
City
Reggio Calabria
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
Country
Italy
Facility Name
Ospedale nostra Signora di Bonaria
City
San Gavino Monreale- CA
Country
Italy
Facility Name
Presidio Ospedaliero di Sassari-Ospedale SS
City
Sassari
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Civili Riuniti di Sciacca
City
Sciacca
Country
Italy
Facility Name
Ospedale Umberto I
City
Talassemie
Country
Italy
Facility Name
Presidio Ospedaliero Centrale
City
Taranto
Country
Italy
Facility Name
Ospedale Infantile Regina Margherita
City
Torino
Country
Italy
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Catharina-ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
Erasmus Medisch Centrum, locatie Sophia
City
Rotterdam
Country
Netherlands
Facility Name
Hospital de Torrecardenas
City
Almeria
Country
Spain
Facility Name
Hospital Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Hospital Cruces
City
Baracaldo
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cadiz
Country
Spain
Facility Name
Hospital De Gran Canaria
City
Canara
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Althaia : Xarxa Assistencial de Manresa
City
Manresa
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Xeral de Vigo
City
Vigo
Country
Spain
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Children's Hospital
City
Taoyuan
Country
Taiwan
Facility Name
Tao-yuan General Hospital
City
Tau-Yuan County
Country
Taiwan
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Bangkok
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
Country
Thailand
Facility Name
Cukurova Universitesi
City
Adana
Country
Turkey
Facility Name
Hacettepe Universitesi
City
Ankara
Country
Turkey
Facility Name
Akdeniz Universitesi
City
Antalya
Country
Turkey
Facility Name
Gaziantep Universitesi
City
Gaziantep
Country
Turkey
Facility Name
Suleyman Demirel
City
Isparta
Country
Turkey
Facility Name
Istanbul Universitesi
City
Istanbul
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
Country
Turkey
Facility Name
Erciyes Universitesi
City
Kayseri
Country
Turkey
Facility Name
Evelina Hospital St. Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
North Middlesex University Hospital
City
London
Country
United Kingdom
Facility Name
The Royal Hospital London
City
London
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
Country
United Kingdom
Facility Name
St. George's Hospital
City
Tooting
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com/
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

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

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