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Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload

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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
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : February 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with transfusional iron overload secondary to thalassemia major , sickle cell disease showing up-trend in SF aged 6 Years or older, may participate after Approval of Ethical committee giving written informed consent.
  • Subjects must have a serum ferritin greater than >2500 ng/mL, a platelet count greater than 100,000/mm3, and a serum creatinine within the normal range.
  • A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for 1 month afterward.
  • The subjects must also have a level of understanding and willingness to cooperate with the confinement and procedures described in the consent form and scheduled by the study site. In addition, he/she must be able to provide voluntary written informed consent.

Exclusion Criteria:

  • Subjects with a past history of agranulocytosis, history of clinically significant gastrointestinal, renal, hepatic ALT > 10 times high normal, OR > 50% increase of serum creatinine from basal value, pulmonary or cardiovascular disease. Patients with a history of tuberculosis, epilepsy, psychosis, glaucoma or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results.
  • Subjects with HIV positive or have active HCV.
  • A history of serious immunologic hypersensitivity to any medication, such as anaphylaxis or angioedema.
  • Participation in a previous investigational drug study within the 30 days preceding screening..
  • Women who are pregnant, or breast-feeding.
  • Current alcohol or drug abuse.
  • An inability to adhere to the designated procedures and restrictions of this protocol.
  • Subjects receiving warfarin, digoxin, or anti-arrhythmic or anti-seizure medications.
  • Subjects with a known allergy to Exjade or DFP that prevents chronic administration.

Information from the National Library of Medicine

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

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Contact: Amira A M Adly, Asst. prof. 0105245837 amiradiabetes@yahoo.com

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Pediatric Hematology clinic, Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Principal Investigator: Mohsen S. Elalfy, professour Ain Shams University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohsen Saleh Elalfy, professour of pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT01511848    
Other Study ID Numbers: AinShamsU
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012
Keywords provided by Mohsen Saleh Elalfy, Ain Shams University:
Iron chelation
Iron balance
Secondary iron overload
1- Beta-thalassemia major patients;
Patients with high iron stores
Serum ferritin consistently > 2500 mcg/l and or increasing trend over previous 12 months
Liver iron >14 mg/g dry weight- by R2 MRI
2- Sickle cell disease
3- Other causes of transfusional iron hemosiderosis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action