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

June 6, 2011
June 13, 2011
February 2010
January 2011   (final data collection date for primary outcome measure)
Ferritin level [ Time Frame: 8 months ] [ Designated as safety issue: No ]
ferritin level in months 4 and 8 of the study
Same as current
Complete list of historical versions of study NCT01369719 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Thalassemia
  • Iron Overload
  • Transfusion Related Complications
  • Drug: osveral
    receive 20 mg/kg daily orally
    Other Name: deferasirox
  • Drug: Desferal
    40-50mg/Kg for 6 nights in each week subcutaneously
    Other Name: Deferoxamine
  • Experimental: Osveral
    20 mg/kg oral osveral daily
    Intervention: Drug: osveral
  • Active Comparator: desferal
    40mg/kg desferal for 6 nights in a week subcutaneously
    Intervention: Drug: Desferal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
May 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01369719
Desferal versus Osveral
No
Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS)
Hormozgan University of Medical Sciences
Not Provided
Principal Investigator: Fariba Mansoori, Resident Hormozgan University of Medical Sciences (HUMS)
Hormozgan University of Medical Sciences
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP