Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Rare Chronic Anemia Patients

Completed · Phase 2

Conditions studied: Anemia, Hemosiderosis

In brief

A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years. The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

Key facts

Study ID

NCT00303329

Run by

Novartis Pharmaceuticals

People needed

184

Starts

2004-03-01

Expected to finish

2008-10-01

Last updated by the study team

2011-05-09

Who can join

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

You may qualify if…

• Patients completed the planned 12-month core study
• Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have 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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Children's Hospital and Research center at Oakland — Oakland, California, United States
• Stanford Hospital — Stanford, California, United States
• Childres's Hospital Boston — Boston, Massachusetts, United States
• New York Presbyterian Hospital — New York, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — La Louvière, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Montreal, Canada
• Novartis Investigative Site — Toronto, Canada
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Le Kremlin-Bicêtre, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Troyes, France
• Novartis Investigative Site — Düsseldorf, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Bologna, Italy
• Novartis Investigative Site — Brindisi, Italy
• Novartis Investigative Site — Cagliari, Italy
• Novartis Investigative Site — Genova, Italy
• Novartis Investigative Site — Milan, Italy
• Novartis Investigative Site — Pavia, Italy

Full record on ClinicalTrials.gov

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