Transfusional Iron Overload Clinical Trial
Official title:
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
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.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | April 2003 |
| Est. primary completion date | April 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Novartis Investigative Site | Cagliari | |
| Italy | Novartis Investigative Site | Genova | |
| Italy | Novartis Investigative Site | Milan | |
| Italy | Novartis Investigative Site | Torino |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment | at 3, 4, 5 years | Yes | |
| Secondary | Change in liver iron content measured by SQUID, at 3, 4, and 5 years | at 3, 4, 5 years | No |
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