Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01369719
• Date of registration: 06/06/2011
• Primary sponsor: Hormozgan University of Medical Sciences
• Public title: Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
• Scientific title: Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With ß-Thalassemia and Intermediate Thalassemia in Bandarabbas
• Date of first enrolment: February 2010
• Target sample size: 138
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01369719
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Fariba Mansoori, Resident
• Affiliation: Hormozgan University of Medical Sciences (HUMS)

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Iron Overload

Thalassemia

Transfusion Related Complications

Intervention(s)

Drug: Desferal

Drug: osveral

Primary Outcome(s)

Ferritin level [Time Frame: 8 months]

Secondary Outcome(s)

Drug side effects [Time Frame: 8 months]

Hemoglobin level [Time Frame: 8 month]

Secondary ID(s)

Desferal versus Osveral

Source(s) of Monetary Support

Please refer to primary and secondary sponsors