Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-09-30

Brief Summary

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This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients

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Detailed Description

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Conditions

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Hemoglobinopathies Myelodysplastic Syndromes Other Inherited or Acquired Anaemia MPD Syndrome Diamond-Blackfan Anemia Other Rare Anaemias Transfusional 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

Group Type EXPERIMENTAL

deferasirox

Intervention Type DRUG

Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily

Interventions

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deferasirox

Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily

Intervention Type DRUG

Other Intervention Names

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ICL670

Eligibility Criteria

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Inclusion Criteria

* Male or female WITH haemoglobinopathy, Myelodysplastic Syndromes or other inherited or acquired anaemia (e.g. MPD, Diamond-blackfan anaemia and other rare anaemias) patients ≥ 18 years and weighing \>40kg.
* Lifetime minimum of \> 20 units of packed red blood cell transfusions
* Normal or minimally abnormal cardiac function

Exclusion Criteria

* Contraindication to MRI scans
* High risk myelodysplastic syndromes patients and patients with other haematological and non-haematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease
* Patients with uncontrolled high blood pressure
* An organ transplant less than 3 months previously

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No