Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | November 2007 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(800)340-6843 |
A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions
This is a clinical research study in patients who have iron overload in the heart due to
chronic blood transfusions.
The study will have 2 treatment groups and will compare the safety and efficacy of chelation
therapy with a medicine called deferasirox (ICL670) with another medicine called
deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best
for treating iron overload in the heart.
Patients will be treated for 12 months (core study phase). Patients who complete the core
study phase will be offered to continue their study treatment in a 12 months extension
phase. During the core and extension, the effects of treatment on iron overload in the heart
and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.
Inclusion criteria:
- Male or female patients, aged 10 years and above, with β-thalassemia major or DBA or
sideroblastic anemia on chronic transfusion therapy, having given written consent to
participate in the study.
- Patients with cardiac iron as measured by a myocardial T2* value that is ≥ 6ms but
not ≥ 20 ms.
- Patients with a lifetime history of at least 50 units of red cell transfusions, and
must be receiving at least ≥10 units/yr of red blood cells transfusions.
- Patients with a left ventricular ejection fraction (LVEF) ≥ 56 % as determined by
cardiovascular magnetic resonance (CMR).
- Patients with liver iron content (LIC) value ≥ 3 mg Fe / g dw, as determined by liver
MRI.
Exclusion criteria:
- Patients with clinical symptoms of cardiac dysfunction.
- Patients unable to undergo study assessments including MRI
- Patients participating in another clinical trial or receiving an investigational
drug.
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
6
sites
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