Status:
COMPLETED
Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Rare Chronic Anemia Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Anemia
Hemosiderosis
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief Summary
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 ol...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant or breast feeding patients
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00303329
Start Date
March 1 2004
End Date
October 1 2008
Last Update
May 9 2011
Active Locations (28)
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1
Children's Hospital and Research center at Oakland
Oakland, California, United States, 94609-1809
2
Stanford Hospital
Stanford, California, United States, 94305
3
Childres's Hospital Boston
Boston, Massachusetts, United States, 02115
4
New York Presbyterian Hospital
New York, New York, United States, 10021