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

Novartis

Status and phase: Completed; Phase 4

Conditions: Other Inherited or Acquired Anaemia; Hemoglobinopathies; Other Rare Anaemias; Diamond-Blackfan Anemia; Transfusional Iron Overload; Myelodysplastic Syndromes; MPD Syndrome

Treatments: Drug: deferasirox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673608

CICL670AAU01

Details and patient eligibility

About

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

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

Deferasirox

Experimental group

Treatment:

Drug: deferasirox