Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01511848|
Recruitment Status : Unknown
Verified February 2012 by Mohsen Saleh Elalfy, Ain Shams University.
Recruitment status was: Not yet recruiting
First Posted : January 19, 2012
Last Update Posted : February 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Beta-thalassemia Major Sickle Cell Disease Iron Hemosiderosis||Drug: DFP (ferriprox) and deferasirox (ICL 670) Drug: DFP, DFO||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||February 2013|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511848
|Contact: Amira A M Adly, Asst. email@example.com|
|Pediatric Hematology clinic, Ain Shams University|
|Principal Investigator:||Mohsen S. Elalfy, professour||Ain Shams University|