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NCT Number: NCT01369719

Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases Transfusion Related Complications

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, 79145-3388, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

osveral

Drug

receive 20 mg/kg daily orally

Other names: deferasirox

Desferal

Drug

40-50mg/Kg for 6 nights in each week subcutaneously

Other names: Deferoxamine

Primary outcomes

  1. Ferritin level

    Time frame: 8 months

    ferritin level in months 4 and 8 of the study

Secondary outcomes

  1. Hemoglobin level

    Time frame: 8 month

    hemoglobin level at months 4 and 8 off the study.

  2. Drug side effects

    Time frame: 8 months

    Leuckopenia, thrombocytopenia

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study title

Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2011
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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