NEWS HIGHLIGHTS
Published Studies Related to Exjade (Deferasirox)
Deferasirox does not induce QT/QTc-prolongation in healthy subjects. [2009.05]
The International Conference on Harmonization (ICH) E14 guidance recommends that almost all drugs should undergo careful clinical testing in a thorough QT/QTc study. Deferasirox (Exjade, ICL670) is a once-daily oral iron chelator, developed for the treatment of blood transfusion-related iron overload. OBJECTIVE: This study was designed to investigate the effect of deferasirox on the QT/QTc interval... CONCLUSIONS: This study demonstrates that deferasirox does not prolong the QT/QTc interval at both therapeutic and supratherapeutic plasma concentrations. It is, therefore, not expected that deferasirox has a negative effect on cardiac repolarization in patients under treatment with this medication.
Absence of an effect of a single-dose deferasirox on the steady-state pharmacokinetics of digoxin. [2008.10]
Deferasirox (Exjade, ICL670) is a potent iron chelator, recently approved as first-line therapy for the treatment of blood-transfusion-related iron overload. Iron deposition in the heart may lead to cardiac dysfunction in patients with iron overload. Thus, the combination of cardiac glycosides and deferasirox is likely to be used in clinical practice. OBJECTIVE: This study was designed to investigate the effect of deferasirox on steady-state pharmacokinetics of digoxin. As digoxin is a P-glycoprotein substrate, the trial also explored the potential of deferasirox to alter the pharmacokinetics of compounds transported by P-glycoprotein in general... CONCLUSIONS: This study shows that single-dose deferasirox has no effect on steady-state pharmacokinetics of digoxin. Therefore, no dose adjustment of digoxin is necessary when deferasirox and digoxin are coadministered. The lack of interaction suggests that deferasirox is unlikely to interact with P-glycoprotein substrates.
Absolute oral bioavailability and disposition of deferasirox in healthy human subjects. [2008.08]
Deferasirox is a novel iron chelator formulated as tablets for dispersion (suspension) for once-a-day oral administration. The current study evaluated the absolute bioavailability of a single 375-mg oral dose of deferasirox administered in the form of tablets compared with a 130-mg intravenous infusion of deferasirox.
Inflammation and oxidant-stress in beta-thalassemia patients treated with iron chelators deferasirox (ICL670) or deferoxamine: an ancillary study of the Novartis CICL670A0107 trial. [2008.06]
BACKGROUND: We assessed whether oxidant-stress and inflammation in beta-thalassemia could be controlled by the novel oral iron chelator deferasirox as effectively as by deferoxamine... CONCLUSIONS: Iron chelation therapy with deferoxamine or with deferasirox was equally effective in decreasing iron burden and malondialdehyde. The possible differential effect of the two chelators on inflammation warrants further investigation.
Effect of food, type of food, and time of food intake on deferasirox bioavailability: recommendations for an optimal deferasirox administration regimen. [2008.04]
Deferasirox (ICL670) is representative of a new class of tridentate iron chelators, formulated as tablets for dispersion...
Clinical Trials Related to Exjade (Deferasirox)
Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers [Completed]
The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a
Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete
both treatment periods as per protocol. For all subjects, in addition to the two treatment
periods, there will be a 21 day screening period, one baseline evaluation (the day preceding
deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS).
Study subjects will be required to remain in the unit from Day - 1 until Day 17. EOS
evaluation (final safety assessment) will be performed 7-10 days after the last dose of
rifampicin.
Cardiac T2* in Beta-Thalassemia Patients on Deferasirox Treatment [Active, not recruiting]
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in
beta-thalassemia patients with deferasirox treatment.
Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload [Active, not recruiting]
This is an open-label, non-randomized, six month, multi-center trial designed to provide
expanded access of deferasirox to patients with congenital disorders of red blood cells and
chronic iron overload from blood transfusions who cannot adequately be treated with locally
approved iron chelators due to documented non-compliance, contraindications, unacceptable
toxicities and/or documented poor response.
Extension Study on Efficacy and Safety of Deferasirox Treatment in Patients With Beta-Thalassemia and Transfusional Hemosiderosis [Active, not recruiting]
Because patients with beta-thalassemia are unable to actively eliminate iron from the body,
toxic and eventually lethal levels of iron can accumulate as a result of repeated blood
transfusions. This study is a 1-year extension study and will evaluate the long-term
efficacy, safety and tolerability of deferasirox.
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients [Active, not recruiting]
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients
with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
|
