NEWS HIGHLIGHTS
Published Studies Related to Exjade (Deferasirox)
Deferasirox reduces iron overload significantly in nontransfusion-dependent
thalassemia: 1-year results from a prospective, randomized, double-blind,
placebo-controlled study. [2012]
Nontransfusion-dependent thalassemia (NTDT) patients may develop iron overload
and its associated complications despite receiving only occasional or no
transfusions... This is the first
randomized study showing that iron chelation with deferasirox significantly
reduces iron overload in NTDT patients with a frequency of overall adverse events
similar to placebo.
The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a
randomized, double-blinded, placebo-controlled trial. [2012]
was conducted... CONCLUSIONS: Patients with mucormycosis treated with deferasirox had a higher
The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial. [2011.09.20]
ObjectivesHost iron availability is fundamental to mucormycosis pathogenesis. The combination of liposomal amphotericin B (LAmB) and deferasirox iron chelation therapy synergistically improved survival in diabetic mice with mucormycosis...
Long-term safety and efficacy of deferasirox (Exjade) for up to 5 years in transfusional iron-overloaded patients with sickle cell disease. [2011.08]
To date, there is a lack of long-term safety and efficacy data for iron chelation therapy in transfusion-dependent patients with sickle cell disease (SCD). To evaluate the long-term safety and efficacy of deferasirox (a once-daily oral iron chelator), patients with SCD completing a 1-year, Phase II, randomized, deferoxamine (DFO)-controlled study entered a 4-year extension, continuing to receive deferasirox, or switching from DFO to deferasirox...
Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up. [2011.07.28]
Patients with beta-thalassemia require lifelong iron chelation therapy from early childhood to prevent complications associated with transfusional iron overload. To evaluate long-term efficacy and safety of once-daily oral iron chelation with deferasirox, patients aged >/= 2 years who completed a 1-year, phase 3, randomized trial entered a 4-year extension study, either continuing on deferasirox (deferasirox cohort) or switching from deferoxamine to deferasirox (crossover cohort)...
Clinical Trials Related to Exjade (Deferasirox)
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload [Recruiting]
RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have
undergone hematopoietic stem cell transplant and have iron overload.
PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in
hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose
deferasirox on labile plasma iron is also examined.
Exjade-Early-Trial [Recruiting]
Study outline: Deferasirox (Exjade®) is regularly used in severe iron overload in order to
avoid organ damage of liver, heart and other organs. It has been proposed, that iron
overload may not only impose damage to other organs but also to the bone marrow and thus
worsen hematopoietic insufficiency in patients with MDS. Patients presenting with low or
INT-1 risk MDS with only mild iron overload will be treated with deferasirox in this study.
It will be analyzed if hematological improvement can be observed during this treatment.
Iron Balance Study of Deferasirox, Deferoxamine and the Combination of Both [Recruiting]
Subjects with thalassemia major require regular transfusion therapy to sustain life. The
iron present in the transfused blood remains in the body where it can cause a variety of
organ dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but
its effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of
chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly
approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even
with good compliance, the iron excretion induced by a given drug exhibits wide
subject-to-subject variability. There is often persistent iron overload of extra hepatic
tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining
the drugs may be a better approach in those subjects at increased risk. The iron balance
studies proposed will permit an assessment of the potential of such a combination to place
subjects in net negative iron balance and the relative effectiveness of the combination in
relation to that of the individual drugs, an additive effect being expected. With such
information, physicians will be able to design individualized chelation regimens that
maximize effectiveness while minimizing side effects by adjusting the ratio and/or the
dosing schedule of the two drugs.
Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load [Not yet recruiting]
Certain percentage of MDS patients develop iron overload. Iron is known to participate in
intracellular reactions that generate free radicals, inducing oxidative stress and
apoptosis, which was found to be increased in MDS patients and consequently resulted in
ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of
the oral iron chelator Deferasirox –Exjade in low risk MDS patients with iron over load by
evaluating changes in several oxidative stress parameters Certain percentage of MDS patients
develop iron overload.
Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload [Recruiting]
This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent
thalassemia patients with iron overload.
Extension Study:
Patients will be treated either with active treatment (deferasirox) or placebo for 12
months (core study phase). Patients who complete the core study phase will be offered to
continue their study with the active treatment (deferasirox) in a 12 months extension phase.
During the core and extension, the effects of treatment on iron overload in the liver will
be evaluated using magnetic resonance imaging (MRI) assessments.
Reports of Suspected Exjade (Deferasirox) Side Effects
Sickle Cell Anaemia With Crisis (526),
Death (480),
Diarrhoea (475),
Pneumonia (277),
Pyrexia (261),
Nausea (253),
Haemoglobin Decreased (204),
Pain (198),
Vomiting (195),
Fatigue (187), more >>
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