Overview
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
Status:
Completed
Completed
Trial end date:
2003-04-01
2003-04-01
Target enrollment:
0
0
Participant gender:
All
All
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-dependent iron overload. The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Deferasirox
Criteria
Inclusion Criteria:- 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 Criteria:
- Pregnant or breast feeding patients
- Patients being considered by the investigator potentially unreliable and/or a history
of non-compliance