Status:
COMPLETED
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Transfusional Iron Overload in β-thalassemia
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- Pregnant or breast feeding patients
- Patients with a history of non-compliance to medical regimens or those considered to be potentially unreliable
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00171210
Start Date
October 1 2004
Last Update
May 30 2011
Active Locations (49)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
3
Stanford Hospital, Division of Oncology
Stanford, California, United States, 94305-5208
4
Children's Memorial Hospital
Chicago, Illinois, United States, 60614