Status:
COMPLETED
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Transfusional Iron Overload
β-thalassemia Major
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully ...
Eligibility Criteria
Inclusion
- Completion of the planned 12-month core trial, (NCT00390858).
- Female patients who have reached menarche and who were sexually active were to 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 from the parent or legal guardian in accordance with the national legislation.
Exclusion
- Pregnant or breast feeding patients
- Patients with a history of non-compliance to medical regimens and patients who are considered by the investigator as potentially unreliable.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00390858
Start Date
September 1 2003
End Date
February 1 2008
Last Update
March 20 2017
Active Locations (4)
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1
Novartis Investigative Site
Lyon, France
2
Novartis Investigative Site
Cagliari, Italy
3
Novartis Investigative Site
Genova, Italy
4
Novartis Investigative Site
Torino, Italy