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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01369719
Other study ID # Desferal versus Osveral
Secondary ID
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


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
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