Cardiac T2* in Beta-Thalassemia Patients on Deferasirox Treatment - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00447694

Purpose

The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.

Condition	Intervention	Phase
Beta-Thalassemia Iron Overload	Drug: Deferasirox	Phase II

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Thalassemia

Drug Information available for: Deferasirox Deferoxamine Deferoxamine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Trial Evaluating Cardiac T2* in Beta-Thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months

Further study details as provided by Novartis:

Primary Outcome Measures:

Cardiac Iron in B thalassemia patients

Secondary Outcome Measures:

Safety and tolerabilty of deferasirox
Changes in liver iron concentration (LIC)
Changes in ventricular ejection fraction
Ferritin, NTBI (LPI and DCI)& iron metabolism parameters
Compliance with deferasirox

Estimated Enrollment:	30
Study Start Date:	February 2006

Eligibility

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

Criteria

Inclusion Criteria:

- Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as > 8 transfusions per year)
Lifetime minimum of 100 previous packed red blood cell transfusions
Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug
Age ≥ 10 years
Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.

Exclusion Criteria:

Ejection Fraction < 56 % measured using steady-state free precession imaging by MRI
Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia
Abnormal laboratory values as defined by the protocol
Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
History of HIV positive test result (ELISA or Western blot)
Uncontrolled systemic hypertension
Second or third degree A-V block
Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year
History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy
History of clinically relevant ocular toxicity related to iron chelation
Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
Pregnancy or breast feeding (documented negative pregnancy test required for study entry)
Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study
Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
Other inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447694

Locations

United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:	Thomas Coates, MD	Childresn's Hospital of Los Angeles
Principal Investigator:	Alexis Thompson, MD	Children's Memorial Hospital of Chicago
Principal Investigator:	Paul Harmatz, MD	Children's Hospital and Research Center at Oakland

More Information

Study ID Numbers:	CICL670AUS04
Study First Received:	March 13, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00447694
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Iron Chelation
Deferasirox
Chelator

Desferal
beta-thalassemia
Iron overload

Study placed in the following topic categories:

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

Thalassemia minor
Genetic Diseases, Inborn
Beta-Thalassemia
Hemoglobinopathies
Iron Overload
Metabolic disorder
Hemoglobinopathy
Iron
Deferoxamine

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009