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Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

This study has been completed.
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01369719
First received: June 6, 2011
Last updated: June 13, 2011
Last verified: January 2010
History of Changes
  Purpose

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
Thalassemia
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369719

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

No publications provided

Responsible Party: Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS)
ClinicalTrials.gov 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:
Thalassemia
Iron overload
transfusion
osveral
desferal

Additional relevant MeSH terms:
Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
 Metabolic Diseases
Deferoxamine
Deferasirox
Siderophores
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013