Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
- Registration Number
- NCT00379483
- Lead Sponsor
- Novartis Pharmaceuticals
- 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-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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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
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Exclusion Criteria
- Pregnant or breast feeding patients
- Patients being considered by the investigator potentially unreliable and/or a history of non-compliance
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Deferasirox -
- Primary Outcome Measures
Name Time Method Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment at 3, 4, 5 years
- Secondary Outcome Measures
Name Time Method Change in liver iron content measured by SQUID, at 3, 4, and 5 years at 3, 4, 5 years
Trial Locations
- Locations (1)
Novartis Investigative Site
🇮🇹Torino, Italy