Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload - Full Text View

Purpose

This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions.

The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart.

Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.

Condition	Intervention	Phase
Transfusional Iron Overload in the Heart Transfusional Hemosiderosis	Drug: Deferasirox	Phase II

Genetics Home Reference related topics:

X-linked sideroblastic anemia

MedlinePlus related topics:

Blood Transfusion and Donation MRI Scans

Drug Information available for:

Deferasirox Deferoxamine Deferoxamine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Open-Label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions

Further study details as provided by Novartis:

Primary Outcome Measures:

Relative change from baseline in myocardial T2* after 12 months treatment with deferasirox versus deferoxamine.

Secondary Outcome Measures:

Absolute and relative change from baseline in liver iron content (LIC) by liver MRI, and serum ferritin after 6 and 12 months treatment with deferasirox vs. deferoxamine

Estimated Enrollment:	192
Study Start Date:	November 2007

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Male or female patients, aged 10 years and above, with β-thalassemia major or DBA or sideroblastic anemia on chronic transfusion therapy, having given written consent to participate in the study.
Patients with cardiac iron as measured by a myocardial T2* value that is ≥ 10 but not ≥ 20 ms.
Patients with a lifetime history of at least 50 units of red cell transfusions, and must be receiving at least ≥10 units/yr of red blood cells transfusions.
Patients with a left ventricular ejection fraction (LVEF) ≥ 56 % as determined by cardiovascular magnetic resonance (CMR).
Patients with liver iron content (LIC) value ≥ 3 mg Fe / g dw, as determined by liver MRI.

Exclusion criteria

Patients with clinical symptoms of cardiac dysfunction.
Patients unable to undergo study assessments including MRI
Patients participating in another clinical trial or receiving an investigational drug.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600938

Contacts


Contact: Novartis Basel	41 61 324 1111

Locations


Egypt
	Novartis Investigative Site	Recruiting
	Cairo, Egypt

Italy
	Novartis Investigative site	Recruiting
	Cagliari, Italy
	Novartis Investigative Site	Recruiting
	Genova, Italy
	Novartis Investigative Site	Recruiting
	Milan, Italy

Lebanon
	Novartis Investigative Site	Recruiting
	Beirut, Lebanon

Thailand
	Novartis Investigative Site	Recruiting
	Bangkok, Thailand

Turkey
	Novartis Investigative Site	Recruiting
	Izmir, Turkey
	Novartis Investigative Site	Recruiting
	Istanbul, Turkey
	Novartis Investigative Site	Recruiting
	Ankara, Turkey

United Arab Emirates
	Novartis Investigative Site	Recruiting
	Dubai, United Arab Emirates

United Kingdom
	Novartis Investigative Site	Recruiting
	London, United Kingdom
	Novartis Investigative Site	Recruiting
	Leeds, United Kingdom

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CICL670A2206
First Received:	January 14, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00600938
Health Authority:	Brazil: Ministry of Health; Colombia: Ministry of Health.; Egypt: Ministry of Health and Population; United Arab Emirates: Ministry of Health; United Kingdom: Research Ethics Committee; United States: Food and Drug Administration; Italy: Ministry of Health; Lebanon: Ministry of Public Health; Malaysia: Ministry of Health; Thailand: Ministry of Public Health; Turkey: Ministry of Health; Venezuela: Ministry of Health & Social Development.

Keywords provided by Novartis:

iron overload

cardiac iron

haemosiderosis

myocardial T2*

left ventricular ejection fraction

LVEF

cardiac dysfunction

thalassaemia

Diamond Blackfan anemia

DBA

sideroblastic anemia

liver MRI

deferasirox

deferoxamine

ICL670

DFO

cardiovascular magnetic resonance imaging

Study placed in the following topic categories:

Metabolic Diseases

Deferasirox

Anemia

Aase syndrome

Iron Metabolism Disorders

Thalassemia

Hemosiderosis

Diamond Blackfan anemia

Anemia, Diamond-Blackfan

Iron Overload

Metabolic disorder

Iron

Deferoxamine

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Iron Chelating Agents

Chelating Agents

Pharmacologic Actions

Siderophores

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00600938