Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Sponsor

Hormozgan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01369719

Collaborator

(none)

138

Enrollment

Location

Arms

14.9

Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thalassemia Iron Overload Transfusion Related Complications	Drug: osveral Drug: Desferal	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ferritin level [8 months]
ferritin level in months 4 and 8 of the study

Secondary Outcome Measures

Hemoglobin level [8 month]
hemoglobin level at months 4 and 8 off the study.
Drug side effects [8 months]
Leuckopenia, thrombocytopenia

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hormozgan University of Medical Sciences (HUMS)	Bandar abbas	Hormozgan	Iran, Islamic Republic of	79145-3388

Sponsors and Collaborators

Hormozgan University of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01369719

Other Study ID Numbers:

Desferal versus Osveral

First Posted:

Jun 9, 2011

Last Update Posted:

Jun 14, 2011

Last Verified:

Jan 1, 2010

Keywords provided by , ,

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2011