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
Sponsor study identifier
interventional
60
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
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Study Completion
February 2013
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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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
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January 6, 2012
Actual (reported)January 19, 2012
Actual (reported)February 2012
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February 2013
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February 2013
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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.
• The primary outcome measure is to measure the change in serum ferritin level from baseline in the 2 combination therapy.
12 months
to determine the safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.
12 months
30 Patients will be treated with combined DFP and deferasirox.
Patients will be treated for 6 days with a combination of deferoxamine and DFP
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
Pediatric Hematology clinic, Ain Shams University
Cairo, Egypt
Elalfy MS, Adly AM, Wali Y, Tony S, Samir A, Elhenawy YI. Efficacy and safety of a novel combination of two oral chelators deferasirox/deferiprone over deferoxamine/deferiprone in severely iron overloaded young beta thalassemia major patients. Eur J Haematol. 2015 Nov;95(5):411-20. doi: 10.1111/ejh.12507. Epub 2015 Mar 27.
Mohsen S. Elalfy, professour
Ain Shams University
First Submitted
January 6, 2012
First Posted
January 19, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia
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
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Study Completion
February 2013
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Last Updated
February 6, 2012
Record last verified: 2012-02
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