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A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia.

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A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. / Cappellini, Maria Domenica; Cohen, Alan; Piga, Antonio; Bejaoui, Mohamed; Perrotta, Silverio; Agaoglu, Leyla; Aydinok, Yesim; Kattamis, Antonis; Kilinc, Yurdanur; Porter, John; Capra, Marcello; Galanello, Renzo; Fattoum, Slaheddine; Drelichman, Guillermo; Magnano, Carmelo; Verissimo, Monica; Athanassiou-Metaxa, Miranda; Giardina, Patricia; Kourakli-Symeonidis, Alexandra; Janka-Schaub, Gritta; Coates, Thomas; Vermylen, Christiane; Olivieri, Nancy; Thuret, Isabelle; Opitz, Herbert; Ressayre-Djaffer, Catherine; Marks, Peter; Alberti, Daniele.

In: BLOOD, Vol. 107, No. 9, 9, 2006, p. 3455-3462.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Cappellini, MD, Cohen, A, Piga, A, Bejaoui, M, Perrotta, S, Agaoglu, L, Aydinok, Y, Kattamis, A, Kilinc, Y, Porter, J, Capra, M, Galanello, R, Fattoum, S, Drelichman, G, Magnano, C, Verissimo, M, Athanassiou-Metaxa, M, Giardina, P, Kourakli-Symeonidis, A, Janka-Schaub, G, Coates, T, Vermylen, C, Olivieri, N, Thuret, I, Opitz, H, Ressayre-Djaffer, C, Marks, P & Alberti, D 2006, 'A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia.', BLOOD, vol. 107, no. 9, 9, pp. 3455-3462. <http://www.ncbi.nlm.nih.gov/pubmed/16352812?dopt=Citation>

APA

Cappellini, M. D., Cohen, A., Piga, A., Bejaoui, M., Perrotta, S., Agaoglu, L., Aydinok, Y., Kattamis, A., Kilinc, Y., Porter, J., Capra, M., Galanello, R., Fattoum, S., Drelichman, G., Magnano, C., Verissimo, M., Athanassiou-Metaxa, M., Giardina, P., Kourakli-Symeonidis, A., ... Alberti, D. (2006). A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. BLOOD, 107(9), 3455-3462. [9]. http://www.ncbi.nlm.nih.gov/pubmed/16352812?dopt=Citation

Vancouver

Cappellini MD, Cohen A, Piga A, Bejaoui M, Perrotta S, Agaoglu L et al. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. BLOOD. 2006;107(9):3455-3462. 9.

Bibtex

@article{eec55b04e3a144409bfb163af1027877,
title = "A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia.",
abstract = "Deferasirox (ICL670) is a once-daily oral iron chelator developed for the treatment of chronic iron overload from blood transfusions. A comparative phase 3 trial was conducted to demonstrate the efficacy of deferasirox in regularly transfused patients with beta-thalassemia aged 2 years or older. Patients were randomized and received treatment with deferasirox (n = 296) or deferoxamine (n = 290), with dosing of each according to baseline liver iron concentration (LIC). The primary endpoint was maintenance or reduction of LIC; secondary endpoints included safety and tolerability, change in serum ferritin level, and net body iron balance. In both arms, patients with LIC values of 7 mg Fe/g dry weight (dw) or higher had significant and similar dose-dependent reductions in LIC and serum ferritin, and effects on net body iron balance. However, the primary endpoint was not met in the overall population, possibly due to the fact that proportionally lower doses of deferasirox relative to deferoxamine were administered to patients with LIC values less than 7 mg Fe/g dw. The most common adverse events included rash, gastrointestinal disturbances, and mild nonprogressive increases in serum creatinine. No agranulocytosis, arthropathy, or growth failure was associated with deferasirox administration. Deferasirox is a promising once-daily oral therapy for the treatment of transfusional iron overload.",
author = "Cappellini, {Maria Domenica} and Alan Cohen and Antonio Piga and Mohamed Bejaoui and Silverio Perrotta and Leyla Agaoglu and Yesim Aydinok and Antonis Kattamis and Yurdanur Kilinc and John Porter and Marcello Capra and Renzo Galanello and Slaheddine Fattoum and Guillermo Drelichman and Carmelo Magnano and Monica Verissimo and Miranda Athanassiou-Metaxa and Patricia Giardina and Alexandra Kourakli-Symeonidis and Gritta Janka-Schaub and Thomas Coates and Christiane Vermylen and Nancy Olivieri and Isabelle Thuret and Herbert Opitz and Catherine Ressayre-Djaffer and Peter Marks and Daniele Alberti",
year = "2006",
language = "Deutsch",
volume = "107",
pages = "3455--3462",
journal = "BLOOD",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "9",

}

RIS

TY - JOUR

T1 - A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia.

AU - Cappellini, Maria Domenica

AU - Cohen, Alan

AU - Piga, Antonio

AU - Bejaoui, Mohamed

AU - Perrotta, Silverio

AU - Agaoglu, Leyla

AU - Aydinok, Yesim

AU - Kattamis, Antonis

AU - Kilinc, Yurdanur

AU - Porter, John

AU - Capra, Marcello

AU - Galanello, Renzo

AU - Fattoum, Slaheddine

AU - Drelichman, Guillermo

AU - Magnano, Carmelo

AU - Verissimo, Monica

AU - Athanassiou-Metaxa, Miranda

AU - Giardina, Patricia

AU - Kourakli-Symeonidis, Alexandra

AU - Janka-Schaub, Gritta

AU - Coates, Thomas

AU - Vermylen, Christiane

AU - Olivieri, Nancy

AU - Thuret, Isabelle

AU - Opitz, Herbert

AU - Ressayre-Djaffer, Catherine

AU - Marks, Peter

AU - Alberti, Daniele

PY - 2006

Y1 - 2006

N2 - Deferasirox (ICL670) is a once-daily oral iron chelator developed for the treatment of chronic iron overload from blood transfusions. A comparative phase 3 trial was conducted to demonstrate the efficacy of deferasirox in regularly transfused patients with beta-thalassemia aged 2 years or older. Patients were randomized and received treatment with deferasirox (n = 296) or deferoxamine (n = 290), with dosing of each according to baseline liver iron concentration (LIC). The primary endpoint was maintenance or reduction of LIC; secondary endpoints included safety and tolerability, change in serum ferritin level, and net body iron balance. In both arms, patients with LIC values of 7 mg Fe/g dry weight (dw) or higher had significant and similar dose-dependent reductions in LIC and serum ferritin, and effects on net body iron balance. However, the primary endpoint was not met in the overall population, possibly due to the fact that proportionally lower doses of deferasirox relative to deferoxamine were administered to patients with LIC values less than 7 mg Fe/g dw. The most common adverse events included rash, gastrointestinal disturbances, and mild nonprogressive increases in serum creatinine. No agranulocytosis, arthropathy, or growth failure was associated with deferasirox administration. Deferasirox is a promising once-daily oral therapy for the treatment of transfusional iron overload.

AB - Deferasirox (ICL670) is a once-daily oral iron chelator developed for the treatment of chronic iron overload from blood transfusions. A comparative phase 3 trial was conducted to demonstrate the efficacy of deferasirox in regularly transfused patients with beta-thalassemia aged 2 years or older. Patients were randomized and received treatment with deferasirox (n = 296) or deferoxamine (n = 290), with dosing of each according to baseline liver iron concentration (LIC). The primary endpoint was maintenance or reduction of LIC; secondary endpoints included safety and tolerability, change in serum ferritin level, and net body iron balance. In both arms, patients with LIC values of 7 mg Fe/g dry weight (dw) or higher had significant and similar dose-dependent reductions in LIC and serum ferritin, and effects on net body iron balance. However, the primary endpoint was not met in the overall population, possibly due to the fact that proportionally lower doses of deferasirox relative to deferoxamine were administered to patients with LIC values less than 7 mg Fe/g dw. The most common adverse events included rash, gastrointestinal disturbances, and mild nonprogressive increases in serum creatinine. No agranulocytosis, arthropathy, or growth failure was associated with deferasirox administration. Deferasirox is a promising once-daily oral therapy for the treatment of transfusional iron overload.

M3 - SCORING: Zeitschriftenaufsatz

VL - 107

SP - 3455

EP - 3462

JO - BLOOD

JF - BLOOD

SN - 0006-4971

IS - 9

M1 - 9

ER -