Overview

Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Deferasirox
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withdrawn in order to participate in this study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