An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload

Completed · Phase 3

Conditions studied: Transfusional Iron Overload in β-thalassemia

In brief

A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years. The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

Key facts

Study ID

NCT00171210

Run by

Novartis Pharmaceuticals

People needed

506

Starts

2004-10-01

Last updated by the study team

2011-05-30

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who completed the 12-month core study (NCT00061750)
• Female patients after menarche and who were sexually active, if they used double-barrier contraception, oral contraceptive plus barrier contraceptive, or had undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
• Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation

You may not qualify if…

• Pregnant or breast feeding patients
• Patients with a history of non-compliance to medical regimens or those considered to be potentially unreliable

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Stanford Hospital, Division of Oncology — Stanford, California, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Children's Hospital Boston, Dept of Hematology — Boston, Massachusetts, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Laken, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Mons, Belgium
• Novartis Investigative Site — Campinas, Brazil
• Novartis Investigative Site — São Paulo, Brazil
• Novartis Investigative Site — Montreal, Canada
• Novartis Investigative Site — Toronto, Canada
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Düsseldorf, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Ulm, Germany

Full record on ClinicalTrials.gov

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