Extension Study of Iron Chelation Therapy With Deferasirox in β-Thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload

This study is ongoing, but not recruiting participants.

First Received: October 14, 2005 Last Updated: July 5, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00303329

Purpose

A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for up to 3 years.

The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

Condition	Intervention	Phase
Transfusional Iron Overload in Patients With Chronic Anemia	Drug: Deferasirox	Phase II

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Anemia Thalassemia

Drug Information available for: Deferasirox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Extension Study of Iron Chelation Therapy With Deferasirox in β-Thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload

Further study details as provided by Novartis:

Primary Outcome Measures:

Long-term safety and tolerability of ICL670

Secondary Outcome Measures:

Change in liver iron content at the end of the study

Estimated Enrollment:	142
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Congenital or acquired chronic anemias patients with transfusional iron overload who have successfully completed the 1-year chelation treatment in the deferasirox trial and considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion Criteria

Pregnant or breast feeding patients

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303329

Locations

United States, California

Stanford, California, United States
United States, Massachusetts

Oakland, Massachusetts, United States

Boston, Massachusetts, United States
United States, New York

New York, New York, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States
Belgium

La Louvière, Belgium

Gent, Belgium

Brugge, Belgium

Leuven, Belgium

Bruxelles, Belgium
Canada

Toronto, Canada

Montreal, Canada
France

Lille, France

Creteil, France

Troyes, France

Le Kremlin Bicetre, France
Germany

Hannover, Germany

Ulm, Germany

Duesseldorf, Germany
Italy

Genova, Italy

Bologna, Italy

Brindisi, Italy

Cagliari, Italy

Milan, Italy

Pavia, Italy

Rome, Italy

Torino, Italy
United Kingdom

London, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CICL670A0108E1
Study First Received:	October 14, 2005
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00303329 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

β-thalassemia
rare chronic anemia
iron overload
deferasirox

Study placed in the following topic categories:

Metabolic Diseases
Deferasirox
Hematologic Diseases
Anemia
Anemia, Hemolytic
Iron Metabolism Disorders
Thalassemia
Anemia, Hemolytic, Congenital

Genetic Diseases, Inborn
Hemoglobinopathies
Chelating Agents
Iron Overload
Hemoglobinopathy
Metabolic Disorder
Iron

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Deferasirox
Anemia
Iron Chelating Agents
Anemia, Hemolytic
Iron Metabolism Disorders

Thalassemia
Pharmacologic Actions
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Iron Overload
Chelating Agents

ClinicalTrials.gov processed this record on May 07, 2009