drugset / Trial / NCT01459718
Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload
NaSingle-groupOpen-labelTreatment
Summary
The primary efficacy endpoint of this interventional study was to evaluate the number of patients achieving a complete response (CR), defined as patients switching from intensive deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2\* value to \>10ms, and continue to maintain their MRI T2\* to values \>10 msec.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deferasirox | Unknown | 20 mg/kg | Oral |
| Subject | Deferasirox | Unknown | 40 mg/kg | Oral |
| Subject | Deferoxamine | Other / unclassified | 40 mg/kg | Subcutaneous |