Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload
Recruitment status was: Not yet recruiting
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.
|Beta-thalassemia Major Sickle Cell Disease Iron Hemosiderosis||Drug: DFP (ferriprox) and deferasirox (ICL 670) Drug: DFP, DFO||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Comparative Study of Efficacy and Safety of Combined Deferiprone (DFP) and Deferasirox Versus DFP and Desferrioxamine (DFO) Therapy in Diseases With Severe Iron Overload|
- to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. [ Time Frame: 12 months ]• The primary outcome measure is to measure the change in serum ferritin level from baseline in the 2 combination therapy.
- to determine the safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP. [ Time Frame: 12 months ]• The secondary outcome measure is to determine the number of patients who will develop adverse reactions upon administering the drugs in combination.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: arm 1
30 Patients will be treated with combined DFP and deferasirox.
Drug: DFP (ferriprox) and deferasirox (ICL 670)
Drug: Ferriprox It will be given orally in the morning Other Name: DFP Initial dose 25/mg/kg 3 times/d (better tolerated if started and then built up over 4 weeks).
Dose may be increased up to 100mg/kg/day guided by serum ferritin. Agranulocytosis risk 1-2%. Monitor TLC and granulocytic count / 2weeks. Patients need to be continually educated about this risk, know that they must stop DFP if they have a fever or infection.
Drug: Deferasirox will be orally administered at a dose of 20 mg/kg once daily at evening for 5 days.
Other Name: ICL670
Active Comparator: arm 2
Patients will be treated for 6 days with a combination of deferoxamine and DFP
Drug: DFP, DFO
Drug: Deferoxamine It will be administered subcutaneously over 8 hours for 5 days at a dose of 40 mg/kg.
Other Name: Desferal, DFO Drug: DFP DFP: will be orally administered at a dose of 75mg/kg orally in 3 divided doses for 7 days
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511848
|Contact: Amira A M Adly, Asst. firstname.lastname@example.org|
|Pediatric Hematology clinic, Ain Shams University||Not yet recruiting|
|Principal Investigator:||Mohsen S. Elalfy, professour||Ain Shams University|