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Efficacy and Safety of Desferal Versus Osveral in Transfusional 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: NCT01369719
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences

Study Description
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Brief Summary:
Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.

Condition or disease Intervention/treatment Phase
Thalassemia Iron Overload Transfusion Related Complications Drug: osveral Drug: Desferal Not Applicable

Detailed Description:
This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Osveral
20 mg/kg oral osveral daily
 Drug: osveral
receive 20 mg/kg daily orally
Other Name: deferasirox
Active Comparator: desferal
40mg/kg desferal for 6 nights in a week subcutaneously
 Drug: Desferal
40-50mg/Kg for 6 nights in each week subcutaneously
Other Name: Deferoxamine


Outcome Measures
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Primary Outcome Measures :
  1. Ferritin level [ Time Frame: 8 months ]
    ferritin level in months 4 and 8 of the study


Secondary Outcome Measures :
  1. Hemoglobin level [ Time Frame: 8 month ]
    hemoglobin level at months 4 and 8 off the study.

  2. Drug side effects [ Time Frame: 8 months ]
    Leuckopenia, thrombocytopenia


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed intermedia or major thalassemia
  • More then 2 years old
  • Serum Ferritin level > 1000
  • Normal Creatinine and Complete Blood Count (CBC)

Exclusion Criteria:

  • HCV, HBV or HIV positive patients
Contacts and Locations
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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): NCT01369719


Locations
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Iran, Islamic Republic of
Hormozgan University of Medical Sciences (HUMS)
Bandar abbas, Hormozgan, Iran, Islamic Republic of, 79145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
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Principal Investigator: Fariba Mansoori, Resident Hormozgan University of Medical Sciences (HUMS)
More Information
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Responsible Party: Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS)
ClinicalTrials.gov Identifier: NCT01369719    
Other Study ID Numbers: Desferal versus Osveral
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: January 2010
Keywords provided by Hormozgan University of Medical Sciences:
Thalassemia
Iron overload
transfusion
osveral
desferal
Additional relevant MeSH terms:
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Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
 Metabolic Diseases
Deferasirox
Deferoxamine
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Siderophores