Status:
COMPLETED
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Transfusional Iron Overload
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-de...
Eligibility Criteria
Inclusion
- Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox
Exclusion
- Pregnant or breast feeding patients
- Patients being considered by the investigator potentially unreliable and/or a history of non-compliance
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00379483
Start Date
July 1 2002
End Date
April 1 2003
Last Update
March 19 2015
Active Locations (4)
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1
Novartis Investigative Site
Cagliari, Italy
2
Novartis Investigative Site
Genova, Italy
3
Novartis Investigative Site
Milan, Italy
4
Novartis Investigative Site
Torino, Italy