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Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

This study has been completed.
Information provided by:
Hormozgan University of Medical Sciences Identifier:
First received: June 6, 2011
Last updated: June 13, 2011
Last verified: January 2010
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 Intervention
Iron Overload
Transfusion Related Complications
Drug: osveral
Drug: Desferal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • Ferritin level [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    ferritin level in months 4 and 8 of the study

Secondary Outcome Measures:
  • Hemoglobin level [ Time Frame: 8 month ] [ Designated as safety issue: No ]
    hemoglobin level at months 4 and 8 off the study.

  • Drug side effects [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Leuckopenia, thrombocytopenia

Enrollment: 138
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01369719

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
Principal Investigator: Fariba Mansoori, Resident Hormozgan University of Medical Sciences (HUMS)
  More Information

Responsible Party: Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS) Identifier: NCT01369719     History of Changes
Other Study ID Numbers: Desferal versus Osveral 
Study First Received: June 6, 2011
Last Updated: June 13, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Iron overload

Additional relevant MeSH terms:
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016