Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Beta-thalassemia Iron Overload

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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deferasirox every day for 77 weeks

Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

Oral deferasirox 30mg/kg/day once per day for 77 weeks.

Interventions

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Deferasirox

Oral deferasirox 30mg/kg/day once per day for 77 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No