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.

Study Overview

• Status: Completed
• Conditions: Iron Overload; Thalassemia; Transfusion Related Complications
• Intervention / Treatment: Drug: osveral; Drug: Desferal

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • Bandar abbas, Hormozgan, Iran, Islamic Republic of, 79145-3388
      • Hormozgan University of Medical Sciences (HUMS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osveral; 20 mg/kg oral osveral daily	Drug: osveral; receive 20 mg/kg daily orally; Other Names: 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 Names: Deferoxamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ferritin level	ferritin level in months 4 and 8 of the study	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin level	hemoglobin level at months 4 and 8 off the study.	8 month
Drug side effects	Leuckopenia, thrombocytopenia	8 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Thalassemia; transfusion; Iron overload; osveral; desferal
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Iron Metabolism Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Iron Overload; Thalassemia; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Siderophores; Deferasirox; Deferoxamine
• Other Study ID Numbers: Desferal versus Osveral