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Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

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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

Tracking Information
First Submitted Date  ICMJE June 6, 2011
First Posted Date  ICMJE June 9, 2011
Last Update Posted Date June 14, 2011
Study Start Date  ICMJE February 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
Ferritin level [ Time Frame: 8 months ]
ferritin level in months 4 and 8 of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • Hemoglobin level [ Time Frame: 8 month ]
    hemoglobin level at months 4 and 8 off the study.
  • Drug side effects [ Time Frame: 8 months ]
    Leuckopenia, thrombocytopenia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
Official Title  ICMJE Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
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.
Detailed Description This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Thalassemia
  • Iron Overload
  • Transfusion Related Complications
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2011)
138
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01369719
Other Study ID Numbers  ICMJE Desferal versus Osveral
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS)
Study Sponsor  ICMJE Hormozgan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fariba Mansoori, Resident Hormozgan University of Medical Sciences (HUMS)
PRS Account Hormozgan University of Medical Sciences
Verification Date January 2010

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