Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload
Summary
Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload Primary Outcome Measures: • The primary outcome measure is to assess efficacy in lowering serum ferritin level(the change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of SF over previous 12 months on single chelator. Secondary Outcome Measures: • The secondary outcome measure is to determine the number of patients who will develop adverse events in order to assess safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.
Timeline
- Start
- 2012-02
- Primary completion
- 2013-02
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Deferasirox | Unknown | 20 mg/kg | Oral |
| Comparator | Deferoxamine | Other / unclassified | 40 mg/kg | Subcutaneous |
| Comparator | Deferiprone | Small molecule | 75 mg/kg | Oral |
| Comparator | Deferiprone | Small molecule | 100 mg/kg | Oral |