Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

• ClinicalTrials.gov Identifier: NCT01369719
• Recruitment Status: Completed
• First Posted: June 9, 2011
• Last Update Posted: June 14, 2011
• Sponsor: Hormozgan University of Medical Sciences
• Information provided by: Hormozgan University of Medical Sciences

Tracking Information

• First Submitted Date: June 6, 2011
• First Posted Date: June 9, 2011
• Last Update Posted Date: June 14, 2011
• Study Start Date: February 2010
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2011)

Ferritin level [ Time Frame: 8 months ]

ferritin level in months 4 and 8 of the study

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Thalassemia
• Iron Overload
• Transfusion Related Complications

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 8, 2011): 138
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT01369719
• Other Study ID Numbers: Desferal versus Osveral
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Fariba Mansoori, Hormozgan University of Medical Sciences (HUMS)
• Study Sponsor: Hormozgan University of Medical Sciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Fariba Mansoori, Resident; Hormozgan University of Medical Sciences (HUMS)

• PRS Account: Hormozgan University of Medical Sciences
• Verification Date: January 2010