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

February 20, 2017 updated by: Novartis

A Study of Magnetic Resonance Imaging Assessment of Cardiac and Liver Iron Load in Patients With Haemoglobinopathies, Myelodysplastic Syndromes (MDS) or Other Anaemias Treated With Exjade® (Deferasirox) (The MILE Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Novarts Investigative Site
      • Brisbane, Australia
        • Novarts Investigative Site
      • Melbourne, Australia
        • Novarts Investigative Site
      • Sydney, Australia
        • Novarts Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deferasirox
Drug: deferasirox
Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily
Other Names:
  • ICL670

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks.
Time Frame: 12 months
12 months
Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup.
Time Frame: 12 months
12 months
Changes in serum ferritin from baseline values to 53 weeks.
Time Frame: 12 months
12 months
Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks
Time Frame: 12 months
12 months
The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI
Time Frame: 12 months
12 months
Changes in markers of iron load levels between baseline and 53 weeks.
Time Frame: 12 months
12 months
The safety and tolerability of deferasirox therapy from baseline to 53 weeks
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670AAU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelodysplastic Syndromes

Clinical Trials on deferasirox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe