Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Thalassemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369719
• Other study ID #: Desferal versus Osveral
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: June 13, 2011
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2010
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Iron Overload
• Thalassemia
• Transfusion Related Complications

Intervention

Drug:
• osveral
receive 20 mg/kg daily orally
• Desferal
40-50mg/Kg for 6 nights in each week subcutaneously

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hormozgan University of Medical Sciences (HUMS)	Bandar abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritin level	ferritin level in months 4 and 8 of the study	8 months	No
Secondary	Hemoglobin level	hemoglobin level at months 4 and 8 off the study.	8 month	No
Secondary	Drug side effects	Leuckopenia, thrombocytopenia	8 months	Yes