Status:
COMPLETED
Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Beta-thalassemia Major
Hemosiderosis
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief Summary
To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety an...
Detailed Description
Iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron. Deferasirox (Exjade, ICL6...
Eligibility Criteria
Inclusion
- Patients completing the planned 12-month core study (NCT00171171)
- Female patients who have reached menarche and who are sexually active must use an effective method of contraception, 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.
- Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the core study protocol, or the planned extension protocol
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00171301
Start Date
June 1 2005
End Date
May 1 2008
Last Update
August 31 2011
Active Locations (5)
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1
Novartis Investigative Site
Cairo, Egypt
2
Novartis Investigative Site
Beirut, Lebanon
3
Novartis Investigative Site
Muscat, Oman
4
Novartis Investigative Site
Riyadh, Saudi Arabia